Back to resultsA Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19) (HORIZON 1)
Primary Purpose
COVID-19 Prevention
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ad26.COV2.S
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 Prevention
Eligibility Criteria
Inclusion Criteria:
- If on medication for a condition, the medication dose must have been stable for at least 4 weeks preceding vaccination
- Participant must be healthy as confirmed by medical history, physical examination, vital signs, and obstetric history performed at Screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled
- Participant will be at second or third trimester of pregnancy, that is, Week 16 to Week 38 of gestation (inclusive), at the time of vaccination, based on ultrasound at the time of screening (or not longer than 10 days prior to vaccination if performed elsewhere)
- Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
- Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- Participant either received their last COVID-19 vaccination with an authorized/licensed COVID-19 vaccine (at least 4 months prior to first study vaccination) or is COVID 19 vaccine-naïve
Exclusion Criteria:
- Participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy)
- Participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen)
- Participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence)
- 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 has a history of any serious, chronic, or progressive neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
- Participant has a positive diagnostic test result (polymerase chain reaction [PCR] based viral ribonucleic acid [RNA] detection) severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at screening or Day 1 (if more than 4 days in between)
- Participant has a history of thrombosis with thrombocytopenia syndrome (TTS), including cerebral venous sinus thrombosis (CVST), or heparin-induced thrombocytopenia (HIT)
- Participant has a history of capillary leak syndrome (CLS)
Sites / Locations
- Medpharmics, LLC
- Meridian Clinical Research, LLC
- Medpharmics, LLC
- Maximos OB/GYN
- Universidade Federal De Minas Gerais - Hospital das Clínicas
- Sociedade Literaria e Caritativa Santo Agostinho - Hospital Sao Jose
- Associacaode Ensino de Marilia LTDA - UNIMAR - Universidade de Marilia
- Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
- Hospital das Clinicas de Porto Alegre
- NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
- CMPC - Consultoria Médica e Pesquisa Clínica
- Clinical Research College
- Ndlovu Elandsdoorn Site
- Shandukani Research Centre
- Stanza Clinical Research Centre : Mamelodi
- Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Groups 1-4: Ad26.COV2.S (One Dose)
Arm Description
Participants who are previously vaccinated (Group 1-3) and participants who are vaccine naïve (Group 4) will receive single dose of Ad26.COV2.S vaccine at standard dose level on Day 1. Participants from group 4 who are no longer pregnant may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.
Outcomes
Primary Outcome Measures
Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination or Until Resolution
Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post vaccination or until resolution. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination or Until Resolution
Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) or until resolution for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
Number of Participants with Unsolicited AEs
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.
Number of Participants with Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
Number of Participants with Medically-attended Adverse Events (MAAEs)
MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Number of Participants with AEs leading to Discontinuation
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After Vaccination
Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/milliliter [EU/mL]), 28 days after vaccination will be reported.
Secondary Outcome Measures
Group 4: Number of Adult Participants with Solicited Local AEs for 7 Days After Booster Vaccination or Until Resolution
Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post booster vaccination or until resolution. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
Group 4: Number of Adult Participants with Solicited Systemic AEs for 7 Days After Booster Vaccination or Until Resolution
Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-booster vaccination (Day of booster vaccination and the subsequent 7 days) or until resolution for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
Group 4: Number of Adult Participants with Unsolicited AEs For 28 Days After Booster Vaccination
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.
Group 4: Number of Adult Participants with SAEs Throughout the Study (From Booster Vaccination Until End of the Study [EOS])
SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Group 4: Number of Adult Participants with AESIs Throughout the Study (From Booster Vaccination Until EOS)
Number of adult participants with AESIs throughout the study (from booster vaccination until EOS) will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
Group 4: Number of Adult Participants with MAAEs Until 6 Months After Booster Vaccination
MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Number of Adult Participants with AEs leading to Discontinuation (During the Entire Study)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Adult Participants with Pregnancy Outcomes
Number of adult participants with pregnancy outcomes (including, live term birth, live preterm birth, stillbirth, and abortion) (non-exhaustive) will be reported.
Number of Adult Participants with Pregnancy Related AEs
Number of adult participants with pregnancy-related AEs including: gestational diabetes, gestational hypertension, premature rupture of membranes, premature labor, premature uterine contractions, poor or restricted fetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine hemorrhage (non-exhaustive) will be reported.
Serological Response to Vaccination as Measured by ELISA and/or Equivalent Assay, at all Blood Collection Timepoints in Adult Participants
Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) and/or equivalent assay, at all blood collection timepoints in adult participants will be reported.
Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days After Vaccination in Adult Participants
Serological response to vaccination as measured by VNA titers, 28 days after vaccination in adult participants will be reported.
Group 4: Serological Response to Booster Vaccination Measured by Binding (S-ELISA and/or Equivalent Assay) in Adult Participants
Serological response to booster vaccination measured by binding (S-ELISA and/or equivalent assay) in adult participants will be reported.
Group 4: Serological Response to Booster Vaccination Measured by Neutralizing (VNA) Antibody Titers in Adult Participants
Serological response to booster vaccination measured by neutralizing (VNA) antibody titers in adult participants will be reported
Serological Response to Vaccination as Measured by ELISA and/or Equivalent Assay in Infants and Neonates
Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) and/or equivalent assay will be reported for neonates and infants (born to adult participants who received vaccination) at birth (in cord blood) and up to 2 months and 6 months of age.
Serological Response to Vaccination as Measured by VNA Titers at Birth in Neonates and Infants
Serological response to vaccination as measured by VNA titers will be reported for neonates and infants (born to adult participants who received vaccination) at birth (in cord blood).
Number of Neonates and Infants with SAEs
Number of neonates and infants (born to adult participants who received vaccination) with SAEs including multisystem inflammatory syndrome in children (MIS-C) from birth up to 12 months of age will be reported.
Number of Neonates and Infants with AESIs
Number of neonates and infants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
Number of Neonates and Infants with MAAEs
Number of neonates and infants (born to adult participants who received vaccination) with MAAEs from birth up to 6 months of age will be reported.
Number of Neonates and Infants with AEs leading to Study Discontinuation
Number of neonates and infants (born to adult participants who received vaccination) with AEs leading to discontinuation from birth up to 12 months of age will be reported.
Number of Neonates and Infants with or without any Complications, Anomalies and Deaths
Number of neonates and infants with or without any complication, anomalies and death will be reported. This will also include normal neonate, term neonate with or without complications, preterm neonate with or without complications, neonatal infection, respiratory distress, congenital anomalies, neonatal death, low birth weight, and small for gestational age measured from birth up to 12 months of age (non exhaustive).
Full Information
NCT ID
NCT04765384
First Posted
February 19, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Vaccines & Prevention B.V.
1. Study Identification
Unique Protocol Identification Number
NCT04765384
Brief Title
A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)
Acronym
HORIZON 1
Official Title
An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
November 29, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
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 purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S administered IM as a 1-dose schedule during the second and/or third trimester of pregnancy, 28 days after vaccination.
Detailed Description
There is an increased risk of severe coronavirus disease-2019 (COVID-19) during pregnancy, as well as an increased risk of adverse birth outcomes. Therefore, the aim of this study is to assess the safety, reactogenicity and immunogenicity of Ad26.COV2.S in adult participants in the second and/or third trimester of pregnancy. Ad26.COV2.S (also known as Ad26COVS1) is a monovalent vaccine composed of a recombinant, replication incompetent adenovirus type 26 (Ad26) vector, constructed to encode the S protein derived from a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) clinical isolate, stabilized in its prefusion conformation. For each adult participant, the total study duration from screening until the last follow-up visit will be approximately 16 months. The study will consist of a screening phase (28 days), vaccination period (study period from vaccination to pregnancy completion/termination) and a follow-up period (up to 12 months post pregnancy completion/termination). For neonates/infants born to the participants in the study will be followed for approximately 12 months postpartum. Safety assessments will include immunogenicity assessments, physical examination, vital signs, clinical safety laboratory assessments, medical, obstetric and delivery history, pregnancy outcome, neonate safety assessment, adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Groups 1-4: Ad26.COV2.S (One Dose)
Arm Type
Experimental
Arm Description
Participants who are previously vaccinated (Group 1-3) and participants who are vaccine naïve (Group 4) will receive single dose of Ad26.COV2.S vaccine at standard dose level on Day 1. Participants from group 4 who are no longer pregnant may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.
Intervention Type
Biological
Intervention Name(s)
Ad26.COV2.S
Other Intervention Name(s)
JNJ-78436735, Ad26COVS1
Intervention Description
Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination or Until Resolution
Description
Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post vaccination or until resolution. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
Time Frame
7 days after vaccination or until resolution (Up to Day 8)
Title
Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination or Until Resolution
Description
Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) or until resolution for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
Time Frame
7 days after vaccination or until resolution (Up to Day 8)
Title
Number of Participants with Unsolicited AEs
Description
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.
Time Frame
28 days after vaccination (Up to Day 29)
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Time Frame
Up to 16 months
Title
Number of Participants with Adverse Events of Special Interest (AESIs)
Description
Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
Time Frame
Up to 16 months
Title
Number of Participants with Medically-attended Adverse Events (MAAEs)
Description
MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Time Frame
6 months after vaccination (Up to Day 183)
Title
Number of Participants with AEs leading to Discontinuation
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to 16 months
Title
Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After Vaccination
Description
Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/milliliter [EU/mL]), 28 days after vaccination will be reported.
Time Frame
28 days after vaccination (Day 29)
Secondary Outcome Measure Information:
Title
Group 4: Number of Adult Participants with Solicited Local AEs for 7 Days After Booster Vaccination or Until Resolution
Description
Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post booster vaccination or until resolution. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
Time Frame
Up to 7 days after booster vaccination or until resolution (up to 16 months)
Title
Group 4: Number of Adult Participants with Solicited Systemic AEs for 7 Days After Booster Vaccination or Until Resolution
Description
Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-booster vaccination (Day of booster vaccination and the subsequent 7 days) or until resolution for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
Time Frame
Up to 7 days after booster vaccination or until resolution (up to 16 months)
Title
Group 4: Number of Adult Participants with Unsolicited AEs For 28 Days After Booster Vaccination
Description
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.
Time Frame
Up to 28 days after booster vaccination
Title
Group 4: Number of Adult Participants with SAEs Throughout the Study (From Booster Vaccination Until End of the Study [EOS])
Description
SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Time Frame
Up to 16 months
Title
Group 4: Number of Adult Participants with AESIs Throughout the Study (From Booster Vaccination Until EOS)
Description
Number of adult participants with AESIs throughout the study (from booster vaccination until EOS) will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
Time Frame
Up to 16 months
Title
Group 4: Number of Adult Participants with MAAEs Until 6 Months After Booster Vaccination
Description
MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Time Frame
6 months after booster vaccination
Title
Number of Adult Participants with AEs leading to Discontinuation (During the Entire Study)
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to 16 months
Title
Number of Adult Participants with Pregnancy Outcomes
Description
Number of adult participants with pregnancy outcomes (including, live term birth, live preterm birth, stillbirth, and abortion) (non-exhaustive) will be reported.
Time Frame
Up to 6 months
Title
Number of Adult Participants with Pregnancy Related AEs
Description
Number of adult participants with pregnancy-related AEs including: gestational diabetes, gestational hypertension, premature rupture of membranes, premature labor, premature uterine contractions, poor or restricted fetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine hemorrhage (non-exhaustive) will be reported.
Time Frame
Up to 6 months
Title
Serological Response to Vaccination as Measured by ELISA and/or Equivalent Assay, at all Blood Collection Timepoints in Adult Participants
Description
Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) and/or equivalent assay, at all blood collection timepoints in adult participants will be reported.
Time Frame
Up to 16 months
Title
Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days After Vaccination in Adult Participants
Description
Serological response to vaccination as measured by VNA titers, 28 days after vaccination in adult participants will be reported.
Time Frame
28 days after vaccination (Day 29)
Title
Group 4: Serological Response to Booster Vaccination Measured by Binding (S-ELISA and/or Equivalent Assay) in Adult Participants
Description
Serological response to booster vaccination measured by binding (S-ELISA and/or equivalent assay) in adult participants will be reported.
Time Frame
Up to 16 months
Title
Group 4: Serological Response to Booster Vaccination Measured by Neutralizing (VNA) Antibody Titers in Adult Participants
Description
Serological response to booster vaccination measured by neutralizing (VNA) antibody titers in adult participants will be reported
Time Frame
Up to 16 months
Title
Serological Response to Vaccination as Measured by ELISA and/or Equivalent Assay in Infants and Neonates
Description
Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) and/or equivalent assay will be reported for neonates and infants (born to adult participants who received vaccination) at birth (in cord blood) and up to 2 months and 6 months of age.
Time Frame
From birth up to 2 and 6 months
Title
Serological Response to Vaccination as Measured by VNA Titers at Birth in Neonates and Infants
Description
Serological response to vaccination as measured by VNA titers will be reported for neonates and infants (born to adult participants who received vaccination) at birth (in cord blood).
Time Frame
At birth
Title
Number of Neonates and Infants with SAEs
Description
Number of neonates and infants (born to adult participants who received vaccination) with SAEs including multisystem inflammatory syndrome in children (MIS-C) from birth up to 12 months of age will be reported.
Time Frame
From birth up to 12 months
Title
Number of Neonates and Infants with AESIs
Description
Number of neonates and infants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
Time Frame
From birth up to 12 months
Title
Number of Neonates and Infants with MAAEs
Description
Number of neonates and infants (born to adult participants who received vaccination) with MAAEs from birth up to 6 months of age will be reported.
Time Frame
From birth up to 6 months
Title
Number of Neonates and Infants with AEs leading to Study Discontinuation
Description
Number of neonates and infants (born to adult participants who received vaccination) with AEs leading to discontinuation from birth up to 12 months of age will be reported.
Time Frame
From birth up to 12 months
Title
Number of Neonates and Infants with or without any Complications, Anomalies and Deaths
Description
Number of neonates and infants with or without any complication, anomalies and death will be reported. This will also include normal neonate, term neonate with or without complications, preterm neonate with or without complications, neonatal infection, respiratory distress, congenital anomalies, neonatal death, low birth weight, and small for gestational age measured from birth up to 12 months of age (non exhaustive).
Time Frame
From birth up to 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
If on medication for a condition, the medication dose must have been stable for at least 4 weeks preceding vaccination
Participant must be healthy as confirmed by medical history, physical examination, vital signs, and obstetric history performed at Screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled
Participant will be at second or third trimester of pregnancy, that is, Week 16 to Week 38 of gestation (inclusive), at the time of vaccination, based on ultrasound at the time of screening (or not longer than 10 days prior to vaccination if performed elsewhere)
Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Participant either received their last COVID-19 vaccination with an authorized/licensed COVID-19 vaccine (at least 4 months prior to first study vaccination) or is COVID 19 vaccine-naïve
Exclusion Criteria:
Participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy)
Participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen)
Participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence)
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 has a history of any serious, chronic, or progressive neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
Participant has a positive diagnostic test result (polymerase chain reaction [PCR] based viral ribonucleic acid [RNA] detection) severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at screening or Day 1 (if more than 4 days in between)
Participant has a history of thrombosis with thrombocytopenia syndrome (TTS), including cerebral venous sinus thrombosis (CVST), or heparin-induced thrombocytopenia (HIT)
Participant has a history of capillary leak syndrome (CLS)
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
Medpharmics, LLC
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Medpharmics, LLC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Maximos OB/GYN
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Universidade Federal De Minas Gerais - Hospital das Clínicas
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Sociedade Literaria e Caritativa Santo Agostinho - Hospital Sao Jose
City
Criciúma
ZIP/Postal Code
88811-508
Country
Brazil
Facility Name
Associacaode Ensino de Marilia LTDA - UNIMAR - Universidade de Marilia
City
Marilia
ZIP/Postal Code
17525-160
Country
Brazil
Facility Name
Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
City
Natal
ZIP/Postal Code
59025-050
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul
City
Porto Alegre
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
Sao Bernardo do Campo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
CMPC - Consultoria Médica e Pesquisa Clínica
City
Sorocaba
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
Clinical Research College
City
São Paulo
ZIP/Postal Code
4534002
Country
Brazil
Facility Name
Ndlovu Elandsdoorn Site
City
Dennilton
ZIP/Postal Code
0485
Country
South Africa
Facility Name
Shandukani Research Centre
City
Johannesburg
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Stanza Clinical Research Centre : Mamelodi
City
Mamelodi East
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
City
Soweto
ZIP/Postal Code
1864
Country
South Africa
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 in Healthy Pregnant Participants (COVID-19)
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