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

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05163652
Collaborator
Yunnan Center for Disease Control and Prevention (Other)
432
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4
10.4
41.6

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 CoronaVac or BBIBP-CorV.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
432 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) Based on the Basic Immunity of Different COVID-19 Inactivated Vaccine in Adults Aged 18 Years and Above
Actual Study Start Date :
Dec 18, 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

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

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

Experimental: 4 months after two doses

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

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

Experimental: 5 months after two doses

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

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

Experimental: 6 months after two doses

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. Adverse reactions/events rate [7 days after vaccination]

    Occurence of adverse reactions/events after vaccination

  4. 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:
  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anning First People's Hospital Anning Yunnan China 650302

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:
NCT05163652
Other Study ID Numbers:
  • 20211101
First Posted:
Dec 20, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022