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.

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) developed by WestVac Biopharma 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 clinical study with two cohorts, i.e. the immuno-bridging observational cohort and the efficacy observational cohort, aims 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

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

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

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

• 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.

Locations
Other Locations
China
Jiangsu Provincial Center for Disease Control and Prevention
RECRUITING
Nanjing
Contact Information
Primary
Fengcai Zhu, Medical
jszfc@jscdc.cn
+86 139 5199 4867
Time Frame
Start Date: 2023-12-19
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 4800
Treatments
Experimental: Experimental group
Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
Active_comparator: Control group
Recombinant COVID-19 Variant Vaccine( Sf9 Cell)
Placebo_comparator: Placebo control group
Placebo control
Related Therapeutic Areas
Sponsors
Collaborators: WestVac Biopharma (Guangzhou) Co., Ltd.
Leads: WestVac Biopharma Co., Ltd.

This content was sourced from clinicaltrials.gov