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)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: Placebo; Biological: Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell); Biological: Recombinant COVID-19 Variant Vaccine (Sf9 Cell)

• Study Type: Interventional
• Enrollment (Estimated): 4800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Fengcai Zhu, Medical; Phone Number: +86 139 5199 4867; Email: jszfc@jscdc.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Jiangsu Provincial Center for Disease Control and Prevention
      • Contact: Fengcai Zhu, Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo control group; Placebo control	Biological: Placebo; boost with saline
Experimental: Experimental group; Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)	Biological: Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell); boost with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
Active Comparator: Control group; Recombinant COVID-19 Variant Vaccine（ Sf9 Cell）	Biological: Recombinant COVID-19 Variant Vaccine (Sf9 Cell); boost with Recombinant COVID-19 Variant Vaccine (Sf9 Cell)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy against COVID-19	Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of symptomatic COVID-19, regardless of severity, 14 days to 6 months after booster vaccination.	14 days to 6 months after vaccination
AEs and ARs	Incidence of adverse events (AEs) and adverse reactions (ARs) 0-7 days after booster vaccination.	0-7 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy against COVID-19	Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of moderate/severe COVID-19 caused by SARS-CoV-2 infection, cases of hospitalization due to COVID-19, and cases of death due to COVID-19, > 14 days to 6 months after booster vaccination.	14 days to 6 months after booster vaccination
Efficacy against COVID-19	Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of symptomatic COVID-19, regardless of severity, 7 days to 6 months after booster vaccination.	7 days to 6 months after booster vaccination
Efficacy against COVID-19	Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of moderate/severe COVID-19 caused by SARS-CoV-2 infection, cases of hospitalization due to COVID-19, and cases of death due to COVID-19, > 7 days to 6 months after booster vaccination.	7 days to 6 months after booster vaccination
AEs and ARs	Incidence of adverse events (AEs) and adverse reactions (ARs) 0-30 days after booster vaccination.	0-30 days after booster vaccination
SAEs and AESIs	Incidence of serious adverse events (SAE) and adverse events of special interest (AESI) within 12 months after booster vaccination.	within 12 months after booster vaccination
Immunogenicity	The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of neutralizing antibodies (true virus and pseudo-virus assay) against SARS-CoV-2 Omicron XBB.1.5 variant and the main circulating strain at that time on day 14 after booster vaccination.	day 14 after booster vaccination
Immunogenicity	The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of neutralizing antibodies (pseudo-virus assay) against SARS-CoV-2 Omicron XBB.1.5 variant and the main circulating strain at that time on day 14, day 30, 3 months and 6 months after booster vaccination.	day 14, day 30, 3 months and 6 months after booster vaccination
Immunogenicity	The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of IgG antibodies against SARS-CoV-2 S-RBD protein on day 14, day 30, 3 months and 6 months after booster vaccination.	day 14, day 30, 3 months and 6 months after booster vaccination

Collaborators and Investigators

• Sponsor: WestVac Biopharma Co., Ltd.
• Collaborators: WestVac Biopharma (Guangzhou) Co., Ltd.
• Investigators: Principal Investigator: Fengcai Zhu, Medical, Jiangsu Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: WSKCT018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No