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 | Unknown Phase 3

• 1 other identifier: WSKCT018
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Efficacy against COVID-19

  14 days to 6 months after booster vaccination

• Efficacy against COVID-19

  7 days to 6 months after booster vaccination

• Efficacy against COVID-19

  7 days to 6 months after booster vaccination

• AEs and ARs

  0-30 days after booster vaccination

• SAEs and AESIs

  within 12 months after booster vaccination

Study Arms (3)

Experimental group

EXPERIMENTAL

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

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

Control group

ACTIVE COMPARATOR

Recombinant COVID-19 Variant Vaccine（ Sf9 Cell）

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

Placebo control group

PLACEBO COMPARATOR

Placebo control

Biological: Placebo

Interventions

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

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

Experimental group

Recombinant COVID-19 Variant Vaccine (Sf9 Cell) BIOLOGICAL

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

Control group

Placebo BIOLOGICAL

boost with saline

Placebo control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Axillary temperature ≥37.3℃.
• SARS-CoV-2 antigen or nucleic acid screening positive during the screening period.
• Anti-SARS-CoV-2 IgM antibody screening positive during the screening period.
• It is in the advanced stage of malignant tumor and the disease control is unstable.
• Female pregnancy (pregnancy test results are positive), lactation period.
• 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.
• 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.
• Have been diagnosed with congenital or acquired immunodeficiency, HIV infection (including anti-HIV antibody positive during the screening period).
• 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.
• Congenital or acquired angioedema/neuropathic edema.
• Asplenia or functional asplenia.
• Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications).
• Received another investigational drug within 1 month prior to receiving the investigational vaccine.
• Received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month.
• Fertile female subjects did not use effective contraception within 1 month prior to enrollment.

Sponsors & Collaborators

• WestVac Biopharma Co., Ltd.: lead
• WestVac Biopharma (Guangzhou) Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fengcai Zhu, Medical

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengcai Zhu, Medical

CONTACT

+86 139 5199 4867; jszfc@jscdc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: December 19, 2023
• Study Start: December 19, 2023
• Primary Completion: July 31, 2024
• Study Completion: January 31, 2025
• Last Updated: April 23, 2024

Record last verified: 2023-12

Locations

CN (1)