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)

SARS-CoV-2 Infection Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05216484
• Other study ID #: 20211103
• Status: Recruiting
• Phase: Phase 3
• Start date: February 18, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Jingsi Yang, Master
• Phone: 86-0871-68334551
• Email: yjs[@]imbcams.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Axillary temperature =37.0 ?.

2. 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.

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
the third dose immunization schedule of SARS-CoV-2 inactivated vaccine

Locations

Country	Name	City	State
China	Xiangyang City Centers for Disease Control and Prevention	Xiangyang	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Hubei Provincial Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2	Seroconversion rate of neutralizing antibodies and IgG against SARS-CoV-2 in serum for the third dose immunization schedule	From 0 days to 6 month after the third dose
Primary	SARS-CoV-2 specific memory B and T cell response	SARS-CoV-2 specific memory B and T cell response for the third dose immunization schedule	From 0 days to 6 month after the third dose
Primary	Adverse reactions/events rate	Occurence of adverse reactions/events after vaccination	7 days after vaccination
Primary	Adverse reactions/events rate	Occurence of adverse reactions/events after vaccination	28 days after vaccination