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

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

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.

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV2 Infection
• Intervention / Treatment: Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)

• Study Type: Interventional
• Enrollment (Anticipated): 880
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Mile, Yunnan, China, 652399
      • Recruiting
      • Mile City Centers for Disease Control and Prevention
      • Contact: Jianmei Zhou; Phone Number: 0873-6122274

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions/events rate	Occurence of adverse reactions/events after vaccination	7 days after vaccination
Adverse reactions/events rate	Occurence of adverse reactions/events after vaccination	28 days after vaccination
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
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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Yunnan Center for Disease Control and Prevention
• Investigators: Principal Investigator: Yan Zheng, Yunnan Center For Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20211102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No