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A Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Booster Vaccination With Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)

NCT06175494 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4800

Last updated 2024-04-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • WestVac Biopharma (Guangzhou) Co., Ltd.

    collaborator UNKNOWN

  • WestVac Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fengcai Zhu, Medical · Jiangsu Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2024-07-31
Completion
2025-01-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06175494 on ClinicalTrials.gov