- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855408
Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults
May 19, 2023 updated by: Jiangsu Province Centers for Disease Control and Prevention
Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults Aged 18 Years or Above: a Multicenter, Parallel Groups, Partially Randomized, Open-label, Blank-controlled Adaptive Platform Trial
This is a multicenter, parallel groups, partially randomized, open-label, blank-controlled adaptive platform study to evaluate the effectiveness of a second COVID-19 vaccine booster in Chinese adults who are charactered as the majority of whom with hybrid immunity of COVID-19 vaccination and COVID-19 breakthrough infection.
Individuals aged 18 years and over, include the elderly over 60 years old or those with underlying diseases (history of underlying medical conditions diagnosed by a clinician, including hypertension, diabetes, heart disease, etc).
The eligible participants with an interval ≥ 4 months after previous SARS-CoV-2 infection (or had never been infected) and ≥ 6 months from the first COVID-19 vaccine booster will be recruited.
Participants who are not willing to receive the second booster but are consent to participate the surveillance for COVID-19, will be included as a blank control.
Informed consent will be acquired from eligible participants.
Other participants who are willing to receive the second booster and participate the surveillance for COVID-19, will be randomly allocated in a ratio of 1: k (k is the number of vaccine types) to the different investigational vaccines, stratified according to age and history of COVID-19 infection.
The symptomatic COVID-19 cases will be reported and documented in both the investigational and control groups.
The occurrence of serious adverse events within 6 months after vaccination will be observed.
Moreover, blood and nasal mucosa samples will be collected on the day 0 before and day 14, month 3 and 6 after the booster vaccination in a subgroup for humoral, cellular and mucosal immunogenicity analysis.
Moreover, oral specimens will be collected once for all participants on the day of enrollment.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
10000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing-Xin Li, PhD
- Phone Number: 86-25-83759913
- Email: jingxin42102209@126.com
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210009
- Jiangsu Provincial Center for Disease Control and Prevention
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Contact:
- Jing-Xin Li, PhD
- Phone Number: 86-25-83759913
- Email: jingxin42102209@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults aged 18 years and over, including the elderly over 60 years and those with underlying diseases.
- Volunteers are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
- ≥ 4 months from the last SARS-CoV-2 infection (or never been infected), and 6 months or more from the first booster immunization of the COVID-19 vaccine.
Exclusion Criteria:
- Volunteers have suspected symptoms of COVID-19 when enrolled, such as dry throat, sore throat, cough, etc.
- The COVID-19 Antigen Quick Test Kit is positive when volunteers are enrolled.
- Fever, temperature > 37.0°C.
- Have received a second COVID-19 vaccine booster immunization.
- Have a history of serious adverse reactions related to the vaccine and/or have a history of severe allergic reactions to any component of the investigational vaccine (only applicable to the vaccine groups).
- Pregnant or lactating women.
- HIV infection, tuberculosis, low immunity caused by disease or long-term medication.
- Acute disease or acute onset of chronic disease.
- Epilepsy and other progressive neurological disorders.
- Other situations that are not suitable for participating in this research, according to the judgment of the researcher.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Subjects are assigned to receive one dose of intramuscularly administered Ad5-nCoV vaccine as the second booster.
|
This vaccine is produced by CanSino Biologics Inc.
|
Experimental: Group 2
Subjects are assigned to receive one dose of aerosolized Ad5-nCoV vaccine as the second booster.
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This vaccine is produced by CanSino Biologics Inc.
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Experimental: Group 3
Subjects are assigned to receive two doses of DelNS1-2019-nCoV-RBD-OPT1 vaccine as the second booster.
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This vaccine is produced by Wantai Biopharmaceutical Company.
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Experimental: Group 4
Subjects are assigned to receive one dose of SYS6006 vaccine as the second booster.
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This vaccine is produced by CSPC Pharmaceutical Group Co., Ltd.
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No Intervention: Group 5
Subjects are not assigned any vaccines served as a blank control.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of COVID-19 from 14 days to 6 months after the booster immunization.
Time Frame: from 14 days to 6 months after the booster dose
|
from 14 days to 6 months after the booster dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of COVID-19 from 7 days to 6 months after the booster immunization.
Time Frame: from 7 days to 6 months the booster dose
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from 7 days to 6 months the booster dose
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The incidence of COVID-19 from 28 days to 6 months after the booster immunization.
Time Frame: from 28 days to 6 months the booster dose
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from 28 days to 6 months the booster dose
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The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 7 days to 6 months after the booster immunization.
Time Frame: from 7 days to 6 months the booster dose
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from 7 days to 6 months the booster dose
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The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 14 days to 6 months after the booster immunization.
Time Frame: from 14 days to 6 months the booster dose
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from 14 days to 6 months the booster dose
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The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 28 days to 6 months after the booster immunization.
Time Frame: from 28 days to 6 months the booster dose
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from 28 days to 6 months the booster dose
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The incidence of hospitalized COVID-19 from 7 days to 6 months after the booster immunization.
Time Frame: from 7 days to 6 months the booster dose
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from 7 days to 6 months the booster dose
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The incidence of hospitalized COVID-19 from 14 days to 6 months after the booster immunization.
Time Frame: from 14 days to 6 months the booster dose
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from 14 days to 6 months the booster dose
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The incidence of hospitalized COVID-19 from 28 days to 6 months after the booster immunization.
Time Frame: from 28 days to 6 months the booster dose
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from 28 days to 6 months the booster dose
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Geometric mean titer (GMT), Geometric mean fold increase (GMFI) and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.
Time Frame: On day 14 after the booster vaccination
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On day 14 after the booster vaccination
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GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.
Time Frame: On month 3 after the booster vaccination
|
On month 3 after the booster vaccination
|
GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.
Time Frame: On month 6 after the booster vaccination
|
On month 6 after the booster vaccination
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GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.
Time Frame: On day 14 after the booster vaccination
|
On day 14 after the booster vaccination
|
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.
Time Frame: On month 3 after the booster vaccination
|
On month 3 after the booster vaccination
|
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.
Time Frame: On month 6 after the booster vaccination
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On month 6 after the booster vaccination
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GMT, GMFI and seroconversion of nasal specific IgA antibodies on day 14 after the booster vaccination in the immunogenic subgroup.
Time Frame: On day 14 after the booster vaccination
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On day 14 after the booster vaccination
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GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 3 after the booster vaccination in the immunogenic subgroup.
Time Frame: On month 3 after the booster vaccination
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On month 3 after the booster vaccination
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GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 6 after the booster vaccination in the immunogenic subgroup.
Time Frame: On month 6 after the booster vaccination
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On month 6 after the booster vaccination
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The incidence of serious adverse events within 6 months after the booster vaccination.
Time Frame: within 6 months after the booster dose
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within 6 months after the booster dose
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The effectiveness for preventing COVID-19 from 7 days after the booster dose will be analyzed stratified based on the S-RBD IgG antibody level at enrollment.
Time Frame: on day 7 after the booster dose
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on day 7 after the booster dose
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The effectiveness for preventing COVID-19 from 14 days after the booster dose will be analyzed stratified based on the S-RBD IgG antibody level at enrollment.
Time Frame: on day 14 after the booster dose
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on day 14 after the booster dose
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The effectiveness for preventing COVID-19 on day 28 after the booster dose will be analyzed stratified based on the S-RBD IgG antibody level at enrollment.
Time Frame: on day 28 after the booster dose
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on day 28 after the booster dose
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Cross-neutralizing antibody levels against other variants on day 14 after the booster vaccination in the immunogenic subgroup.
Time Frame: On day 14 after the booster vaccination
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On day 14 after the booster vaccination
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Cross-neutralizing antibody levels against other variants on month 3 after the booster vaccination in the immunogenic subgroup.
Time Frame: On month 3 after the booster vaccination
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On month 3 after the booster vaccination
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Cross-neutralizing antibody levels against other variants on month 6 after the booster vaccination in the immunogenic subgroup.
Time Frame: On month 6 after the booster vaccination
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On month 6 after the booster vaccination
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Effectiveness and immunogenicity after the second booster immunization will be subgroup analyzed in the elderly over 60 years old and those with underlying diseases.
Time Frame: from 14 days to 6 months after the booster dose
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from 14 days to 6 months after the booster dose
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The impact of the human genome on the effect of vaccination.
Time Frame: from 14 days to 6 months after the booster dose
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from 14 days to 6 months after the booster dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jing-Xin Li, PhD, Jiangsu Provincial Center for Diseases Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 18, 2023
Primary Completion (Anticipated)
May 18, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
May 10, 2023
First Submitted That Met QC Criteria
May 10, 2023
First Posted (Actual)
May 11, 2023
Study Record Updates
Last Update Posted (Actual)
May 22, 2023
Last Update Submitted That Met QC Criteria
May 19, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSVCT178
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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