Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) Based on Different COVID-19 Inactivated Vaccine in Adults Aged 18 Years and Above

Phase 3

• Conditions: SARS-CoV-2 Infection
• Interventions: Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)

• Registration Number: NCT05163652
• Lead Sponsor: Chinese Academy of Medical Sciences

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 3, 4, 5, or 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-17
• Study Start: 2021-12-18
• Study First Posted: 2021-12-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-08-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

1. Axillary temperature ≤37.0 ℃.
2. aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.
3. Proven legal identity, could come each visit.
4. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.

Exclusion Criteria

1. Persons with a clear history of SARS-CoV-2 infection.
2. Using blood products after basic immunization or receiving immunosuppressive therapy.
3. 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.
4. Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
5. 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.
6. Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
7. Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
8. Immunization with any vaccine within 14 days.
9. Any other situations judged by investigators as not suitable for participating in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5 months after two doses	SARS-CoV-2 Vaccine, Inactivated (Vero Cell)	group 1：the third does was given 5 months after two doses CoronaVac group 2：the third does was given 5 months after two doses BBIBP-CorV group 3：the third does was given 5 months after one does CoronaVac and one does BBIBP-CorV
6 months after two doses	SARS-CoV-2 Vaccine, Inactivated (Vero Cell)	group 1：the third does was given 6 months after two doses CoronaVac group 2：the third does was given 6 months after two doses BBIBP-CorV group 3：the third does was given 6 months after one does CoronaVac and one does BBIBP-CorV
3 months after two doses	SARS-CoV-2 Vaccine, Inactivated (Vero Cell)	group 1：the third does was given 3 months after two doses CoronaVac group 2：the third does was given 3 months after two doses BBIBP-CorV group 3：the third does was given 3 months after one does CoronaVac and one does BBIBP-CorV
4 months after two doses	SARS-CoV-2 Vaccine, Inactivated (Vero Cell)	group 1：the third does was given 4 months after two doses CoronaVac group 2：the third does was given 4 months after two doses BBIBP-CorV group 3：the third does was given 4 months after one does CoronaVac and one does BBIBP-CorV

Primary Outcome Measures

Name	Time	Method
Adverse reactions/events rate	28 days after vaccination	Occurence of adverse reactions/events after vaccination
SARS-CoV-2 specific memory B and T cell response	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	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

Trial Locations

Locations (1)

Anning First People's Hospital; 🇨🇳 Anning, Yunnan, China