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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05164731

Collaborator

Yunnan Center for Disease Control and Prevention (Other)

880

Enrollment

Location

Arms

10.4

Anticipated Duration (Months)

84.2

Patients Per Site Per Month

Study Details

Study Description

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 Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2 Infection	Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

880 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above After a Two-dose Schedule

Actual Study Start Date :

Dec 16, 2021

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3 months after two doses the third does was given 3 months after two doses	Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell) the third does was given 3, 4, 5 or 6 months after two doses
Experimental: 4 months after two doses the third does was given 4 months after two doses	Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell) the third does was given 3, 4, 5 or 6 months after two doses
Experimental: 5 months after two doses the third does was given 5 months after two doses	Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell) the third does was given 3, 4, 5 or 6 months after two doses
Experimental: 6 months after two doses the third does was given 6 months after two doses	Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell) the third does was given 3, 4, 5 or 6 months after two doses

Outcome Measures

Primary Outcome Measures

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
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
Adverse reactions/events rate [7 days after vaccination]
Occurence of adverse reactions/events after vaccination
Adverse reactions/events rate [28 days after vaccination]
Occurence of adverse reactions/events after vaccination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Axillary temperature ≤37.0 ℃.
aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mile City Centers for Disease Control and Prevention	Mile	Yunnan	China	652399

Sponsors and Collaborators

Chinese Academy of Medical Sciences
Yunnan Center for Disease Control and Prevention

Investigators

Principal Investigator: Yan Zheng, Yunnan Center for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jingsi Yang, Senior Technologist, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05164731

Other Study ID Numbers:

20211102

First Posted:

Dec 21, 2021

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Feb 16, 2022