Back to resultsHeterologous Boost Immunization With an Aerosolised Ad5-nCoV After Two-dose Priming With an Inactivated SARS-CoV-2 Vaccine
Primary Purpose
COVID-19
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aerosolized Ad5-nCoV
Inactivated SARS-CoV-2 vaccine
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring SARS-CoV-2, Aerosolised COVID-19 vaccine, Recombinant Ad5 Vector, Inactivated Vaccine, Safety, Immunogenicity
Eligibility Criteria
Inclusion Criteria:
- Health subjects aged ≥18 years.
- Have received two-dose inactivated SARS-CoV-2 vaccine before 6 months or more.
- The subject can provide with informed consent and sign informed consent form (ICF).
- The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
Exclusion Criteria:
- Have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
- Be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
- Women with positive urine pregnancy test.
- Have acute febrile diseases and infectious diseases.
- Axillary temperature>37.0℃.
- Have serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured in the field).
- Have severe chronic diseases or condition in progress cannot be smoothly controlled, such as asthma, diabetes, thyroid disease.
- Congenital or acquired angioedema / neuroedema.
- Have the history of urticaria 1 year before receiving the investigational vaccine.
- Have asplenia or functional asplenia.
- Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities.
- Have history of SARS-CoV-2 infection or COVID-19.
- Have symptoms of upper respiratory tract infection.
- Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with SARS-CoV-2.
- Any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent.
Sites / Locations
- Jiangsu Provincial Center for Diseases Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Arm Description
Subjects in safety cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
Subjects in immunogenicity cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
Subjects in immunogenicity cohort will receive one homologous booster dose of ICV.
Outcomes
Primary Outcome Measures
Incidence of adverse reactions within 28 days after the booster dose.
Incidence of adverse reactions within 28 days after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.
Secondary Outcome Measures
Incidence of adverse reactions within 30 minutes after the booster dose.
Incidence of adverse reactions within 30 minutes after the booster dose.
Incidence of adverse reactions within 14 days after the booster dose.
Incidence of adverse reactions within 14 days after the booster dose.
Incidence of adverse events within 28 days after the booster dose.
Incidence of adverse events within 28 days after the booster dose.
Incidence of serious adverse events (SAE) till the 6 months after the booster dose.
Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.
Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.
Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.
GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose.
GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus as compared to baseline on day 14, month 3 and 6 after the booster dose.
GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.
GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.
Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose.
Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline.
GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline.
GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.
GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.
The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination.
The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination.
Full Information
NCT ID
NCT05204589
First Posted
January 21, 2022
Last Updated
May 14, 2022
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Anhui Provincial Center for Disease Control and Prevention, Shandong Province Centers for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Yunnan Center for Disease Control and Prevention, Chongqing Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT05204589
Brief Title
Heterologous Boost Immunization With an Aerosolised Ad5-nCoV After Two-dose Priming With an Inactivated SARS-CoV-2 Vaccine
Official Title
Heterologous Prime-boost Immunization With an Aerosolised Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Two-dose Priming With an Inactivated SARS-CoV-2 Vaccine in Adults Aged 18 Years and Above: a Multicenter, Open-label, Partially Parallel-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 22, 2022 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Anhui Provincial Center for Disease Control and Prevention, Shandong Province Centers for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Yunnan Center for Disease Control and Prevention, Chongqing Center for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, open-label, partially radomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV-IH) after two-dose priming with an inactivated SARS-CoV-2 vaccine (ICV) in adults aged 18 years and above. 10420 healthy subjects aged over or equal to 18 years whom have received two doses of ICV before 6 months or more, will be recruited from six provinces in China in this study.Of them, 10000 eligible participants in an open cohort will receive a booster dose of Ad5-nCoV-IH to evaluate the safety profile. Another 420 participants were involved in immunogenicity cohort and randomized in a ratio of 1:1 to receive a boost of Ad5-nCoV-IH or ICV. The ICV homologous to the priming series will be supplied as the booster. The occurrence of adverse reactions within 28 days and serious adverse events within 6 months after vaccination will be observed in all participants. In addition, blood and saliva samples will be collected from all participants in immunogenicity cohort on the day 0 before and 14, 28 and month 3 and 6 after the booster vaccination. Each subject will remain in this study for approximately 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, Aerosolised COVID-19 vaccine, Recombinant Ad5 Vector, Inactivated Vaccine, Safety, Immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects in safety cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
Arm Title
Group B
Arm Type
Experimental
Arm Description
Subjects in immunogenicity cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
Arm Title
Group C
Arm Type
Experimental
Arm Description
Subjects in immunogenicity cohort will receive one homologous booster dose of ICV.
Intervention Type
Biological
Intervention Name(s)
Aerosolized Ad5-nCoV
Intervention Description
Aerosolized Ad5-nCoV is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.1 ml / dose, contains 1×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation.
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 vaccine
Intervention Description
Inactivated SARS-CoV-2 vaccine is homologous to the priming series which have been administered to the subjects, produced by SinoVac Biotech Co,. Ltd, Beijing Institute of Biological Products Co,. Ltd, Wuhan Institute of Biological Products Co,. Ltd, or Biokangtai.
Primary Outcome Measure Information:
Title
Incidence of adverse reactions within 28 days after the booster dose.
Description
Incidence of adverse reactions within 28 days after the booster dose.
Time Frame
Within 28 days the booster dose
Title
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.
Description
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.
Time Frame
On day 28 after the booster dose
Secondary Outcome Measure Information:
Title
Incidence of adverse reactions within 30 minutes after the booster dose.
Description
Incidence of adverse reactions within 30 minutes after the booster dose.
Time Frame
Within 30 minutes after the booster dose
Title
Incidence of adverse reactions within 14 days after the booster dose.
Description
Incidence of adverse reactions within 14 days after the booster dose.
Time Frame
Within 14 days after the booster dose
Title
Incidence of adverse events within 28 days after the booster dose.
Description
Incidence of adverse events within 28 days after the booster dose.
Time Frame
Within 28 days after the booster dose
Title
Incidence of serious adverse events (SAE) till the 6 months after the booster dose.
Description
Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.
Time Frame
Within 6 months after the booster dose
Title
Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.
Description
Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.
Time Frame
On day 28 after the boost vaccination
Title
GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose.
Description
GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus as compared to baseline on day 14, month 3 and 6 after the booster dose.
Time Frame
On day 14, month 3 and 6 after the booster dose
Title
GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.
Description
GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.
Time Frame
At month 3, 6, and 12 after the boost vaccination.
Title
Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose.
Description
Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose.
Time Frame
On day 14, day 28 and month 3 and 6 after the booster dose
Title
GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline.
Description
GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline.
Time Frame
On day 28 after the booster dose
Title
GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.
Description
GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.
Time Frame
On day 28 after the booster dose
Title
The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination.
Description
The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination.
Time Frame
On day 14 after the booster vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Health subjects aged ≥18 years.
Have received two-dose inactivated SARS-CoV-2 vaccine before 6 months or more.
The subject can provide with informed consent and sign informed consent form (ICF).
The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
Exclusion Criteria:
Have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
Be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
Women with positive urine pregnancy test.
Have acute febrile diseases and infectious diseases.
Axillary temperature>37.0℃.
Have serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured in the field).
Have severe chronic diseases or condition in progress cannot be smoothly controlled, such as asthma, diabetes, thyroid disease.
Congenital or acquired angioedema / neuroedema.
Have the history of urticaria 1 year before receiving the investigational vaccine.
Have asplenia or functional asplenia.
Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities.
Have history of SARS-CoV-2 infection or COVID-19.
Have symptoms of upper respiratory tract infection.
Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with SARS-CoV-2.
Any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengcai Zhu, Prof
Organizational Affiliation
Jiangsu Provincial Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Provincial Center for Diseases Control and Prevention
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
12. IPD Sharing Statement
Learn more about this trial
Heterologous Boost Immunization With an Aerosolised Ad5-nCoV After Two-dose Priming With an Inactivated SARS-CoV-2 Vaccine
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