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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

Primary Purpose

SARS-CoV2 Infection

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV2 Infection

Eligibility Criteria

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

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

Sites / Locations

  • Mile City Centers for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

3 months after two doses

4 months after two doses

5 months after two doses

6 months after two doses

Arm Description

the third does was given 3 months after two doses

the third does was given 4 months after two doses

the third does was given 5 months after two doses

the third does was given 6 months after two doses

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

First Posted
December 14, 2021
Last Updated
February 14, 2022
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Yunnan Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05164731
Brief Title
Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Yunnan Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 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
880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3 months after two doses
Arm Type
Experimental
Arm Description
the third does was given 3 months after two doses
Arm Title
4 months after two doses
Arm Type
Experimental
Arm Description
the third does was given 4 months after two doses
Arm Title
5 months after two doses
Arm Type
Experimental
Arm Description
the third does was given 5 months after two doses
Arm Title
6 months after two doses
Arm Type
Experimental
Arm Description
the third does was given 6 months after two doses
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
Intervention Description
the third does was given 3, 4, 5 or 6 months after two doses
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
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingsi Yang, Master
Phone
86-0871-68334551
Email
yjs@imbcams.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zheng
Organizational Affiliation
Yunnan Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mile City Centers for Disease Control and Prevention
City
Mile
State/Province
Yunnan
ZIP/Postal Code
652399
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmei Zhou
Phone
0873-6122274

12. IPD Sharing Statement

Plan to Share IPD
No

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

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