Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above (6 Months After Two Doses)
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Adverse reactions/events rate
Study Overview
Brief Summary
To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Axillary temperature ≤37.0 ℃.
- •aged 18 years and above, after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.
- •Proven legal identity, could come each visit.
- •Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.
Exclusion Criteria
- •Persons with a clear history of SARS-CoV-2 infection.
- •Using blood products after basic immunization or receiving immunosuppressive therapy.
- •Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
- •Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
- •History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
- •Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
- •Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
- •Immunization with any vaccine within 14 days.
- •Any other situations judged by investigators as not suitable for participating in this study.
Outcomes
Primary Outcomes
Adverse reactions/events rate
Time Frame: 28 days after vaccination
Occurence of adverse reactions/events after vaccination
SARS-CoV-2 specific memory B and T cell response
Time Frame: From 0 days to 6 month after the third dose
SARS-CoV-2 specific memory B and T cell response for the third dose immunization schedule
Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2
Time Frame: From 0 days to 6 month after the third dose
Seroconversion rate of neutralizing antibodies and IgG against SARS-CoV-2 in serum for the third dose immunization schedule
Secondary Outcomes
No secondary outcomes reported
Investigators
Jingsi Yang
Senior Technologist
Chinese Academy of Medical Sciences