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

ConditionCOVID-19
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestVac Biopharma Co., Ltd.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Biological/Vaccine

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

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

    Biological/Vaccine

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

  • control group

    Biological/Vaccine

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

  • Placebo group

    Biological/Vaccine

    saline

Treatment groups

4,950 Participants
are divided into 4 treatment groups
Group A: Experimental group 1Experimental treatment 1 intervention
Group B: Experimental group 2Experimental treatment 1 intervention
Group C: Control groupActive comparator 1 intervention
Group D: Placebo control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
14 days after vaccination
2

AE and AR

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

Time frame
0-7 days after vaccination

Secondary outcomes

1

Secondary Efficacy against COVID-19

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.

Time frame
>7 days after booster vaccination
2

Secondary Efficacy against COVID-19

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

Time frame
> 7 days and > 14 days after booster vaccination
3

Secondary Safety

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

Time frame
0-30 days after booster vaccination
4

Secondary Safety

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

WestVac Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: