Back to resultsA Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2 (Amplify)
Primary Purpose
Coronavirus Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ad26.COV2.S
Sponsored by
About this trial
This is an interventional prevention trial for Coronavirus Disease
Eligibility Criteria
Inclusion Criteria:
- Cohort 1: Participant received Ad26.COV2.S in VAC31518COV3001. The interval between the Ad26.COV2.S primary vaccination should preferably be greater than or equal to (>=) 6 months prior to study vaccination on VAC31518COV2008, however a window of maximum -20 days is allowed; Cohort 2: Participant completed primary vaccination with a 2-dose regimen of BNT162b2 vaccine. The last dose of BTN162b2 should preferably be >=6 months prior to study vaccination on COV2008, however a window of a maximum of -20 days is allowed
- Participant must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
- Participant agrees to not donate bone marrow, blood, and blood products from the study vaccine administration until 3 months after receiving the study vaccine
- Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- Participant must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the Coronavirus disease (COVID-19) signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the eCOA questionnaires
Exclusion Criteria:
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned study vaccination; randomization at a later date is permitted at the discretion of the investigator. Please notify the sponsor (or medical monitor) of this decision
- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine
- Participant received treatment with immunoglobulins (Ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study
- Participant has a known history of confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection
- Participant has a history of heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia
- Participant has a history of acute polyneuropathy (example. Guillain-Barre syndrome)
- History of capillary leak syndrome
Sites / Locations
- Central Phoenix Medical Clinic
- Synexus Clinical Research US, Inc
- Anaheim Clinical Trials, LLC
- Ark Clinical Research
- Velocity Clinical Research
- Velocity Clinical Research, Hallandale Beach
- Research Centers of America, LLC
- Synexus Clinical Research US, Inc
- Synexus Clinical Research US, Inc
- Optimal Research
- Johnson County Clin-Trials
- University of Kentucky
- Clinical Trials Management, LLC
- Massachusetts General Hospital
- Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
- Rochester Clinical Research, Inc
- Velocity Clinical Research, Anderson
- Accellacare US Inc
- Coastal Carolina Research Center
- Crofoot Research Center
- Velocity Clinical Research, Salt Lake City
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1: Group 1: Ad26.COV2.S (Dose Level 1)
Cohort 1: Group 2: Ad26.COV2.S (Dose Level 2)
Cohort 1: Group 3: Ad26.COV2.S (Dose Level 3)
Cohort 2: Group 4: Ad26.COV2.S (Dose Level 1)
Cohort 2: Group 5: Ad26.COV2.S (Dose Level 2)
Cohort 2: Group 6: Ad26.COV2.S (Dose Level 3)
Arm Description
Participants who have previously received primary vaccination with Ad26.COV2.S will receive single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1.
Participants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1.
Participants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1.
Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1.
Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1.
Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1.
Outcomes
Primary Outcome Measures
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 original strain (Wuhan, 2019, whole genome sequence) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer less than (<) lower limit of quantification (LLOQ) and post-booster titer greater than or equal to (>=) 4*LLOQ or (2) Pre-booster titer greater than (>) LLOQ and post-booster titer >=4*pre-booster titer value.
Cohort 1: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. GMT against original strain was assessed by virus neutralization assay (VNA).
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value.
Cohort 1: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. GMT against original strain was assessed by VNA.
Cohort 1: Percentage of Participants With Serological Response Against the Delta Variant 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against leading variant of high consequence or concern (delta variant) 14 days after Ad26.COV2.S booster vaccination (5*10^10 vp Dose Level) after completing primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer <LLOQ and post-booster titer >=4*LLOQ or (2) Pre-booster titer >LLOQ and post-booster titer >=4*pre-booster titer value. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
GMTs of neutralizing antibodies against leading variant of high consequence or concern (delta variant) 14 days After Ad26.COV2.S booster vaccination (5*10^10 vp dose level) after completing primary vaccination with Ad26.COV2.S were reported. GMT against Delta Variant was assessed by VNA. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5*10^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S (5*10^10 vp Dose Level)
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5*10^10 vp dose level) were reported. GMT against Delta variant was assessed by VNA. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol. Lower limit of Quantification (LLOQ) was 65.
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
Percentage of participants with serological response against SARS-CoV-2 original strain, 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Percentage of participants with serological response against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were planned to be reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-dose 1 titer <LLOQ, then post-vaccination titer >=4*LLOQ. (2) If pre-dose 1 titer >LLOQ, then post-vaccination titer >=4*pre-dose 1 value (titer).
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Delta Variant 14 Days After Booster Vaccination (5×10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (Delta) 14 days after booster vaccination (5×10^10 vp dose level) after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer). Data for this outcome measure was not planned to be collected and analyzed for Cohort 2: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Booster Vaccination (5×10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 14 days after booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA. Data for this outcome measure was not planned to be collected and analyzed for Cohort 2: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Cohort 2: Percentage of Participants With Seropositive Response to Vaccination Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing Primary Vaccination With 2-dose BNT162b2 (Pfizer BNT162b2 External Samples)
Percentage of participants with seropositive response to vaccination against the SARS-CoV-2 leading variant of high consequence or concern (Delta) 2 weeks to 2 months after completing primary vaccination with 2-dose BNT162b2 were planned to be reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ. or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value.
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA.
Secondary Outcome Measures
Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) After Ad26.COV2.S Booster Vaccination
Participants who received the booster dose were asked to note the occurrences of injection site pain, erythema, and swelling at the study vaccine injection site in e-Diary daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs After Ad26.COV2.S Booster Vaccination
Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.
Cohorts 1 and 2: Number of Participants With Unsolicited AEs After Ad26.COV2.S Booster Vaccination
Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Cohorts 1 and 2: Number of Participants With Serious Adverse Events (SAEs) After Ad26.COV2.S Booster Vaccination
SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Cohorts 1 and 2: Number of Participants With Adverse Events of Special Interest (AESIs) After Ad26.COV2.S Booster Vaccination
Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals.
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 14 Days After Ad26.COV2.S Booster Vaccination
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination were reported. GMT against original strain was assessed by VNA.
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination were reported. GMT was assessed by VNA.
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Cohort 1: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Enzyme-linked Immunosorbent Assay (ELISA)
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV-2 Proteins by ELISA were planned to be reported.
Cohort 1: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Meso Scale Discovery (MSD)
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV-2 Proteins by MSD were planned to be reported.
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Percentage of participants with serological response to vaccination against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Percentage of participants with serological response to vaccination against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Antibody GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Antibody GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Percentage of participants with serological response to vaccination against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Percentage of participants with serological response to vaccination against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Cohort 2: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Cohort 2: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Cohort 2: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by ELISA
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV- 2 proteins by ELISA were planned to be reported.
Cohort 2: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by MSD
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV- 2 proteins by MSD were planned to be reported.
Cohorts 1 and 2: Number of Participants With Antibodies Binding to the SARS-CoV-2 Nucleocapsid (N) Protein at Day 1 as Assessed by N-Serology
Number of participants with antibodies binding to the SARS-CoV-2 nucleocapsid (N) protein at Day 1 as assessed by N-serology will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Full Information
NCT ID
NCT04999111
First Posted
August 3, 2021
Last Updated
January 17, 2023
Sponsor
Janssen Vaccines & Prevention B.V.
1. Study Identification
Unique Protocol Identification Number
NCT04999111
Brief Title
A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
Acronym
Amplify
Official Title
A Randomized, Double-blind, Phase 2 Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Ad26.COV2.S Administered as Booster Vaccination in Adults 18 Years of Age and Older Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
October 27, 2021 (Actual)
Study Completion Date
November 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Vaccines & Prevention B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purposes of this study are to demonstrate the non-inferiority (NI) of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels, administered greater than or equal to (>=) 6 months after single-dose primary vaccination with Ad26.COV2.S, compared to the neutralizing antibody response to the original strain induced by single-dose primary vaccination with Ad26.COV2.S; To demonstrate the NI of the neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 virus particle (vp) dose level, administered >= 6 months after single-dose primary vaccination with Ad26.COV2.S (5*10^10 vp dose level), compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by single-dose primary vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, if feasible; To demonstrate the NI of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels administered >=6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the original strain induced by 2-dose primary vaccination with Pfizer BNT162b2; To demonstrate the NI of neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, administered >= 6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by 2-dose primary vaccination with Pfizer BNT162b2, if feasible.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1541 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: Group 1: Ad26.COV2.S (Dose Level 1)
Arm Type
Experimental
Arm Description
Participants who have previously received primary vaccination with Ad26.COV2.S will receive single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1.
Arm Title
Cohort 1: Group 2: Ad26.COV2.S (Dose Level 2)
Arm Type
Experimental
Arm Description
Participants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1.
Arm Title
Cohort 1: Group 3: Ad26.COV2.S (Dose Level 3)
Arm Type
Experimental
Arm Description
Participants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1.
Arm Title
Cohort 2: Group 4: Ad26.COV2.S (Dose Level 1)
Arm Type
Experimental
Arm Description
Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1.
Arm Title
Cohort 2: Group 5: Ad26.COV2.S (Dose Level 2)
Arm Type
Experimental
Arm Description
Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1.
Arm Title
Cohort 2: Group 6: Ad26.COV2.S (Dose Level 3)
Arm Type
Experimental
Arm Description
Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1.
Intervention Type
Biological
Intervention Name(s)
Ad26.COV2.S
Other Intervention Name(s)
JNJ-78436735, VAC31518
Intervention Description
Participants will receive IM injection of Ad26.COV2.S.
Primary Outcome Measure Information:
Title
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
Description
Percentage of participants with serological response against SARS-CoV-2 original strain (Wuhan, 2019, whole genome sequence) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer less than (<) lower limit of quantification (LLOQ) and post-booster titer greater than or equal to (>=) 4*LLOQ or (2) Pre-booster titer greater than (>) LLOQ and post-booster titer >=4*pre-booster titer value.
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)
Title
Cohort 1: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
Description
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. GMT against original strain was assessed by virus neutralization assay (VNA).
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)
Title
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
Description
Percentage of participants with serological response against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value.
Time Frame
28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Title
Cohort 1: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
Description
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. GMT against original strain was assessed by VNA.
Time Frame
28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Title
Cohort 1: Percentage of Participants With Serological Response Against the Delta Variant 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
Description
Percentage of participants with serological response against leading variant of high consequence or concern (delta variant) 14 days after Ad26.COV2.S booster vaccination (5*10^10 vp Dose Level) after completing primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer <LLOQ and post-booster titer >=4*LLOQ or (2) Pre-booster titer >LLOQ and post-booster titer >=4*pre-booster titer value. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
Description
GMTs of neutralizing antibodies against leading variant of high consequence or concern (delta variant) 14 days After Ad26.COV2.S booster vaccination (5*10^10 vp dose level) after completing primary vaccination with Ad26.COV2.S were reported. GMT against Delta Variant was assessed by VNA. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S
Description
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5*10^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Time Frame
28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Title
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S (5*10^10 vp Dose Level)
Description
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5*10^10 vp dose level) were reported. GMT against Delta variant was assessed by VNA. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol. Lower limit of Quantification (LLOQ) was 65.
Time Frame
28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Title
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
Description
Percentage of participants with serological response against SARS-CoV-2 original strain, 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
Description
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Description
Percentage of participants with serological response against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were planned to be reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-dose 1 titer <LLOQ, then post-vaccination titer >=4*LLOQ. (2) If pre-dose 1 titer >LLOQ, then post-vaccination titer >=4*pre-dose 1 value (titer).
Time Frame
2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Title
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Description
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Time Frame
2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Title
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Delta Variant 14 Days After Booster Vaccination (5×10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
Description
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (Delta) 14 days after booster vaccination (5×10^10 vp dose level) after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer). Data for this outcome measure was not planned to be collected and analyzed for Cohort 2: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Booster Vaccination (5×10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
Description
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 14 days after booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA. Data for this outcome measure was not planned to be collected and analyzed for Cohort 2: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants as pre planned in the protocol.
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 2: Percentage of Participants With Seropositive Response to Vaccination Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing Primary Vaccination With 2-dose BNT162b2 (Pfizer BNT162b2 External Samples)
Description
Percentage of participants with seropositive response to vaccination against the SARS-CoV-2 leading variant of high consequence or concern (Delta) 2 weeks to 2 months after completing primary vaccination with 2-dose BNT162b2 were planned to be reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ. or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value.
Time Frame
2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Title
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Description
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA.
Time Frame
2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Secondary Outcome Measure Information:
Title
Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) After Ad26.COV2.S Booster Vaccination
Description
Participants who received the booster dose were asked to note the occurrences of injection site pain, erythema, and swelling at the study vaccine injection site in e-Diary daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).
Time Frame
Up to 7 days after booster vaccination (Up to Day 8)
Title
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs After Ad26.COV2.S Booster Vaccination
Description
Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.
Time Frame
Up to 7 days after booster vaccination (Up to Day 8)
Title
Cohorts 1 and 2: Number of Participants With Unsolicited AEs After Ad26.COV2.S Booster Vaccination
Description
Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Time Frame
Up to 28 days after booster vaccination (Up to Day 29)
Title
Cohorts 1 and 2: Number of Participants With Serious Adverse Events (SAEs) After Ad26.COV2.S Booster Vaccination
Description
SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame
From booster vaccination (Day 1) until data cut-off date (up to 4.5 months)
Title
Cohorts 1 and 2: Number of Participants With Adverse Events of Special Interest (AESIs) After Ad26.COV2.S Booster Vaccination
Description
Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals.
Time Frame
From booster vaccination (Day 1) until data cut-off date (up to 4.5 months)
Title
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Description
Percentage of participants with serological response against SARS-CoV-2 original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Description
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 14 Days After Ad26.COV2.S Booster Vaccination
Description
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination were reported. GMT against original strain was assessed by VNA.
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination
Description
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Description
Percentage of participants with serological response against SARS-CoV-2 original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Time Frame
28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Title
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Description
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Time Frame
28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Title
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination
Description
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination were reported. GMT was assessed by VNA.
Time Frame
28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Title
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination
Description
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Time Frame
28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Title
Cohort 1: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Enzyme-linked Immunosorbent Assay (ELISA)
Description
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV-2 Proteins by ELISA were planned to be reported.
Time Frame
From booster vaccination (Day 1) until data cut-off date (up to 4.5 months)
Title
Cohort 1: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Meso Scale Discovery (MSD)
Description
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV-2 Proteins by MSD were planned to be reported.
Time Frame
From booster vaccination (Day 1) until data cut-off date (up to 4.5 months)
Title
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Description
Percentage of participants with serological response to vaccination against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Description
Percentage of participants with serological response to vaccination against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Description
Antibody GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Description
Antibody GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Time Frame
14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Title
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Description
Percentage of participants with serological response to vaccination against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Time Frame
28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Title
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Description
Percentage of participants with serological response to vaccination against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Time Frame
28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Title
Cohort 2: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Description
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Time Frame
28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Title
Cohort 2: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Description
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Time Frame
28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Title
Cohort 2: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by ELISA
Description
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV- 2 proteins by ELISA were planned to be reported.
Time Frame
From booster vaccination (Day 1) until data cut-off date (up to 4.5 months)
Title
Cohort 2: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by MSD
Description
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV- 2 proteins by MSD were planned to be reported.
Time Frame
From booster vaccination (Day 1) until data cut-off date (up to 4.5 months)
Title
Cohorts 1 and 2: Number of Participants With Antibodies Binding to the SARS-CoV-2 Nucleocapsid (N) Protein at Day 1 as Assessed by N-Serology
Description
Number of participants with antibodies binding to the SARS-CoV-2 nucleocapsid (N) protein at Day 1 as assessed by N-serology will be reported. Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (October 2023).
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cohort 1: Participant received Ad26.COV2.S in VAC31518COV3001. The interval between the Ad26.COV2.S primary vaccination should preferably be greater than or equal to (>=) 6 months prior to study vaccination on VAC31518COV2008, however a window of maximum -20 days is allowed; Cohort 2: Participant completed primary vaccination with a 2-dose regimen of BNT162b2 vaccine. The last dose of BTN162b2 should preferably be >=6 months prior to study vaccination on COV2008, however a window of a maximum of -20 days is allowed
Participant must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
Participant agrees to not donate bone marrow, blood, and blood products from the study vaccine administration until 3 months after receiving the study vaccine
Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Participant must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the Coronavirus disease (COVID-19) signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the eCOA questionnaires
Exclusion Criteria:
Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned study vaccination; randomization at a later date is permitted at the discretion of the investigator. Please notify the sponsor (or medical monitor) of this decision
Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine
Participant received treatment with immunoglobulins (Ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study
Participant has a known history of confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection
Participant has a history of heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia
Participant has a history of acute polyneuropathy (example. Guillain-Barre syndrome)
History of capillary leak syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Vaccines & Prevention B.V. Clinical Trial
Organizational Affiliation
Janssen Vaccines & Prevention B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Central Phoenix Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Ark Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Velocity Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Research Centers of America, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Velocity Clinical Research, Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Accellacare US Inc
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Crofoot Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Velocity Clinical Research, Salt Lake City
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
We'll reach out to this number within 24 hrs