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)

NCT05216484 | Unknown Phase 3

• 1 other identifier: 20211103
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Study Arms (4)

two doses CoronaVac group

EXPERIMENTAL

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

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

two doses BBIBP-CorV

EXPERIMENTAL

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

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

first does CoronaVac and second does BBIBP-CorV

EXPERIMENTAL

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

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

first does BBIBP-CorV and second does CoronaVac

EXPERIMENTAL

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

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

Interventions

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

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

first does BBIBP-CorV and second does CoronaVac; first does CoronaVac and second does BBIBP-CorV; two doses BBIBP-CorV; two doses CoronaVac group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Hubei Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Xiangyang City Centers for Disease Control and Prevention

Xiangyang, Hubei, 441022, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yeqing Tong

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingsi Yang, Master

CONTACT

86-0871-68334551; yjs@imbcams.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Technologist

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: January 31, 2022
• Study Start: February 18, 2022
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)