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

NCT05911061
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Unknown
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Participants
4,950
clinicaltrials.gov
Lead sponsor
WestVac Biopharma Co., Ltd.
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Start date
2024-12-30
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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
clinicaltrials.gov
Short title
A Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination
clinicaltrials.gov
Official title
A Multicenter, Randomized, Double-Blind, Controlled, 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 in Population Aged 18 Years Old and Above
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 3
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Study type
Interventional
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Completion date
2025-12-30
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First posted
2023-06-20
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Registry last updated
2024-07-25
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Primary completion date
2025-06-30
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Start date
2024-12-30
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Participants
4,950
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Participant count basis
Estimated
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Planned participants
4,950
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Protocol amendments
0
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Registry sponsor category
Industry
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Lead sponsor
WestVac Biopharma Co., Ltd.
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05911061
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ClinicalTrials.gov ID
NCT05911061
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Efficacy against COVID-19

    Timeframe: 14 days after vaccination

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

  2. AE and AR

    Timeframe: 0-7 days after vaccination

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

  1. Secondary Efficacy against COVID-19

    Timeframe: >7 days after booster vaccination

    Efficacy against the first occurrence of a virologically confirmed (PCR-positive) case of symptomatic COVID-19 \> 7 days after booster vaccination in subjects, regardless of severity.

  2. Secondary Efficacy against COVID-19

    Timeframe: > 7 days and > 14 days after booster vaccination

    Efficacy against first occurrence of virologically confirmed (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 and \> 14 days after booster vaccination

  3. Secondary Safety

    Timeframe: 0-30 days after booster vaccination

    Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days after booster vaccination.

  4. Secondary Safety

    Timeframe: within 12 months after booster vaccination

    Incidence of serious adverse events (SAE) and adverse events of special interest (AESI) within 12 months after booster vaccination.

  5. Secondary Immunogenicity indicator 1

    Timeframe: day 14, day 30 and 3 months after booster vaccination

    The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of neutralizing antibodies against SARS-CoV-2 variants (based on the current variants at same time) on day 14, day 30 and 3 months after booster vaccination.

  6. Secondary Immunogenicity indicator 2

    Timeframe: day 14, day 30 and 3 months after booster vaccination

    Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific binding antibodies were measured on day 14, day 30 and 3 months after booster vaccination.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  1. Subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects.
  2. Basic or booster immunization with COVID-19 vaccine ≥6 months.
  3. ≥3 months of SARS-CoV-2 infection history, or never infected.
  4. 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.

  1. Axillary temperature ≥37.3℃.
  2. SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
  3. Anti-SARS-CoV-2 IgM antibody was 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. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs.
  7. 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.
  8. Have been diagnosed with congenital or acquired immunodeficiency, HIV infection.
  9. 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.
  10. Congenital or acquired angioedema/neuroedema.
  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 immunization.
  17. Abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine.
  18. 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.
Sources for eligibility
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (4)