Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Booster Vaccination With Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) for the Prevention of SARS-CoV-2 Infection in a Population of 18 Years of Age and Older.
Brief Summary

The Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) developed by WestVacBiopharma Co., Ltd. is a monovalent modified vaccine designed against Omicron XBB.1.5.This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinicalstudy with two cohorts, i.e. the immuno-bridging observational cohort and the efficacyobservational cohort, aims to evaluate the efficacy, safety, and immunogenicity ofbooster vaccination with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) forthe prevention of SARS-CoV-2 infection in a population of 18 years of age and older.

Detailed Description

Not Provided

Recruiting
COVID-19

Biological: Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)

boost with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)

Biological: Recombinant COVID-19 Variant Vaccine (Sf9 Cell)

boost with Recombinant COVID-19 Variant Vaccine (Sf9 Cell)

Biological: Placebo

boost with saline

Eligibility Criteria

Inclusion Criteria:

1. Subjects aged 18 years and above, including those with underlying diseases or
immunocompromised.

2. Basic or booster vaccination with COVID-19 vaccine ≥3 months.

3. No history of SARS-CoV-2 infection history within 3 months, or never infected.

4. Have the ability to understand research procedures, with informed consent,
voluntarily sign informed consent form, and be able to comply with the requirements
of clinical study protocol.

Exclusion Criteria:

1. Axillary temperature ≥37.3℃.

2. SARS-CoV-2 antigen or nucleic acid screening positive during the screening period.

3. Anti-SARS-CoV-2 IgM antibody screening positive during the screening period.

4. It is in the advanced stage of malignant tumor and the disease control is unstable.

5. Female pregnancy (pregnancy test results are positive), lactation period.

6. Suffering from serious cardiovascular diseases, such as arrhythmia, conduction
block, myocardial infarction, heart failure etc.; suffering from severe hypertension
that can not be controlled by drugs.

7. Suffering from other serious chronic conditions such as uncontrolled asthma,
diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney
disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other
neurological/psychiatric conditions.

8. Have been diagnosed with congenital or acquired immunodeficiency, HIV infection
(including anti-HIV antibody positive during the screening period).

9. People who are allergic to any component of the investigational vaccine and have a
history of severe allergies or vaccine allergic reactions in the past.

10. Congenital or acquired angioedema/neuropathic edema.

11. Asplenia or functional asplenia.

12. Thrombocytopenia or other clotting disorders (which may cause intramuscular
injection contraindications).

13. Received another investigational drug within 1 month prior to receiving the
investigational vaccine.

14. Received subunit or inactivated vaccine within 14 days prior to receiving the
investigational vaccine, or received live attenuated vaccine within 1 month.

15. Fertile female subjects did not use effective contraception within 1 month prior to
enrollment.

16. Fertile female and male subjects have pregnancy plans and sperm/egg donation plans
from the screening period to 3 months after vaccination.

17. Medical, psychological, social, or other conditions that, in the investigator's
judgment, are inconsistent with the protocol or affect the subject's signing of
informed consent.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China

Investigator: Fengcai Zhu, Medical

Contacts

Fengcai Zhu, Medical
+86 139 5199 4867
jszfc@jscdc.cn

Fengcai Zhu, Medical, Principal Investigator
Jiangsu Provincial Center for Disease Control and Prevention

WestVac Biopharma (Guangzhou) Co., Ltd.
NCT Number
MeSH Terms
COVID-19
Vaccines