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)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: SARS-CoV-2 Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05216484

20211103

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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480 participants in 4 patient groups

two doses CoronaVac group

Experimental group

Description:

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

Treatment:

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

two doses BBIBP-CorV

Experimental group

Description:

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

Treatment:

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

first does CoronaVac and second does BBIBP-CorV

Experimental group

Description:

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

Treatment:

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

first does BBIBP-CorV and second does CoronaVac

Experimental group

Description:

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

Treatment:

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