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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)

Primary Purpose

SARS-CoV-2 Infection

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

SARS-CoV-2 Vaccine, Inactivated (Vero Cell)

About this trial

This is an interventional prevention trial for SARS-CoV-2 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Xiangyang City Centers for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

two doses CoronaVac group

two doses BBIBP-CorV

first does CoronaVac and second does BBIBP-CorV

first does BBIBP-CorV and second does CoronaVac

Arm Description

the third does was given 6 months after two doses CoronaVac group

the third does was given 6 months after two doses BBIBP-CorV

the third does was given 6 months after first does CoronaVac and second does BBIBP-CorV

the third does was given 6 months after first does BBIBP-CorV and second does CoronaVac

Outcomes

Primary Outcome Measures

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

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

Adverse reactions/events rate

Occurence of adverse reactions/events after vaccination

Adverse reactions/events rate

Occurence of adverse reactions/events after vaccination

Secondary Outcome Measures

Full Information

NCT ID

NCT05216484

First Posted

January 27, 2022

Last Updated

May 17, 2022

Sponsor

Chinese Academy of Medical Sciences

Collaborators

Hubei Provincial Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT05216484

Brief 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)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 18, 2022 (Actual)

Primary Completion Date

October 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

Collaborators

Hubei Provincial Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2 Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

two doses CoronaVac group

Arm Type

Experimental

Arm Description

the third does was given 6 months after two doses CoronaVac group

Arm Title

two doses BBIBP-CorV

Arm Type

Experimental

Arm Description

the third does was given 6 months after two doses BBIBP-CorV

Arm Title

first does CoronaVac and second does BBIBP-CorV

Arm Type

Experimental

Arm Description

the third does was given 6 months after first does CoronaVac and second does BBIBP-CorV

Arm Title

first does BBIBP-CorV and second does CoronaVac

Arm Type

Experimental

Arm Description

the third does was given 6 months after first does BBIBP-CorV and second does CoronaVac

Intervention Type

Biological

Intervention Name(s)

SARS-CoV-2 Vaccine, Inactivated (Vero Cell)

Intervention Description

the third dose immunization schedule of SARS-CoV-2 inactivated vaccine

Primary Outcome Measure Information:

Title

Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2

Description

Seroconversion rate of neutralizing antibodies and IgG against SARS-CoV-2 in serum for the third dose immunization schedule

Time Frame

From 0 days to 6 month after the third dose

Title

SARS-CoV-2 specific memory B and T cell response

Description

SARS-CoV-2 specific memory B and T cell response for the third dose immunization schedule

Time Frame

From 0 days to 6 month after the third dose

Title

Adverse reactions/events rate

Description

Occurence of adverse reactions/events after vaccination

Time Frame

7 days after vaccination

Title

Adverse reactions/events rate

Description

Occurence of adverse reactions/events after vaccination

Time Frame

28 days after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jingsi Yang, Master

Phone

86-0871-68334551

yjs@imbcams.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yeqing Tong

Organizational Affiliation

Hubei Provincial Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xiangyang City Centers for Disease Control and Prevention

City

Xiangyang

State/Province

Hubei

ZIP/Postal Code

441022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shengchun Tang, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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)

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