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)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Xiangyang, Hubei, China, 441022
      • Recruiting
      • Xiangyang City Centers for Disease Control and Prevention
      • Contact: Shengchun Tang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Axillary temperature ≤37.0 ℃.
2. 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.
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
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: two doses CoronaVac group; the third does was given 6 months after two doses CoronaVac group	Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell); the third dose immunization schedule of SARS-CoV-2 inactivated vaccine
EXPERIMENTAL: two doses BBIBP-CorV; the third does was given 6 months after two doses BBIBP-CorV	Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell); the third dose immunization schedule of SARS-CoV-2 inactivated vaccine
EXPERIMENTAL: first does CoronaVac and second does BBIBP-CorV; the third does was given 6 months after first does CoronaVac and second does BBIBP-CorV	Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell); the third dose immunization schedule of SARS-CoV-2 inactivated vaccine
EXPERIMENTAL: first does BBIBP-CorV and second does CoronaVac; the third does was given 6 months after first does BBIBP-CorV and second does CoronaVac	Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell); the third dose immunization schedule of SARS-CoV-2 inactivated vaccine

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: Hubei Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2022
• Primary Completion (ANTICIPATED): October 30, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (ACTUAL): January 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 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: 20211103

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