A Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination

NCT05911061 | Not Yet Recruiting Phase 3

• 1 other identifier: WSKCT015
• Study Type: interventional
• Target: 4,950
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination to Evaluate Efficacy, Safety and Immunogenicity

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Efficacy against COVID-19

  Efficacy against the first occurrence of a virologically confirmed (PCR-positive) case of symptomatic COVID-19, regardless of severity, 14 days after booster vaccination.

  14 days after vaccination

• AE and AR

  Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after booster vaccination.

  0-7 days after vaccination

Secondary Outcomes (6)

• Secondary Efficacy against COVID-19

  >7 days after booster vaccination

• Secondary Efficacy against COVID-19

  > 7 days and > 14 days after booster vaccination

• Secondary Safety

  0-30 days after booster vaccination

• Secondary Safety

  within 12 months after booster vaccination

• Secondary Immunogenicity indicator 1

  day 14, day 30 and 3 months after booster vaccination

Study Arms (4)

Experimental group 1

EXPERIMENTAL

high dose

Biological: High dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell)

Experimental group 2

EXPERIMENTAL

low dose

Biological: Low dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell)

Control group

ACTIVE COMPARATOR

Control group

Biological: control group

Placebo control group

PLACEBO COMPARATOR

Placebo control group

Biological: Placebo group

Interventions

High dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) BIOLOGICAL

boost with high dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell)

Experimental group 1

Low dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) BIOLOGICAL

boost with low dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell)

Experimental group 2

control group BIOLOGICAL

boost with Recombinant Variant COVID-19 Vaccine(sf9 cell)

Control group

Placebo group BIOLOGICAL

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 and immunocompromised subjects.
• Basic or booster immunization with COVID-19 vaccine ≥6 months.
• ≥3 months of SARS-CoV-2 infection history, or never infected.
• Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols.

You may not qualify if:

• Axillary temperature ≥37.3℃.
• SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
• Anti-SARS-CoV-2 IgM antibody was 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.
• Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs.
• Have 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.
• People who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past.
• Congenital or acquired angioedema/neuroedema.
• 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

MeSH Terms

Conditions

COVID-19

Interventions

Control Groups

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

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

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 20, 2023
• Study Start: December 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07