RecruitingNCT06175494Updated Apr 23, 2024

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 Phase 3 interventional study of Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) and Recombinant COVID-19 Variant Vaccine (Sf9 Cell) in COVID-19, sponsored by WestVac Biopharma Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by WestVac Biopharma Co., Ltd. · Phase 3, Interventional, and Prevention

From the registry’s dates

Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
Started Dec 2023; still recruiting 2 years 9 months later.

Phase: Phase 3
Study type: Interventional
Enrollment: 4,800
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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 studied

COVID-19

Browse trials for

COVID-19 7,640

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 4,800 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

WestVac Biopharma Co., Ltd. is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 4,800 participants (estimated)

Study arms

Experimental
Experimental group
Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
Biological: 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)
Placebo comparator
Placebo control group
Placebo control
Biological: Placebo

Interventions

BiologicalRecombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
boost with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
BiologicalRecombinant COVID-19 Variant Vaccine (Sf9 Cell)
boost with Recombinant COVID-19 Variant Vaccine (Sf9 Cell)
BiologicalPlacebo
boost with saline

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 0-7 days after vaccination

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: day 14, day 30, 3 months and 6 months after booster vaccination

Study locations

1 of 1 sites recruiting

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06175494
Lead sponsor: WestVac Biopharma Co., Ltd.
Collaborators: WestVac Biopharma (Guangzhou) Co., Ltd.
Responsible party: Sponsor
First posted: Dec 19, 2023
Start date: Dec 19, 2023
Primary completion: Jul 31, 2024 (estimated)
Completion: Jan 31, 2025 (estimated)
Last update: Apr 23, 2024

Study contacts

Fengcai Zhu, Medical

Contact

jszfc@jscdc.cn

+86 139 5199 4867

Fengcai Zhu, Medical

principal investigator · Jiangsu Provincial Center for Disease Control and Prevention

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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