Clinical trial NCT05911061: A Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: WestVac Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-20
Enrollment: 4950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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 Healthy Population Aged 18 Years Old and Above

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Efficacy against COVID-19
timeFrame: 14 days after vaccination
measure: AE and AR
timeFrame: 0-7 days after vaccination
Secondary outcomes:
measure: Secondary Efficacy against COVID-19
timeFrame: >7 days after booster vaccination
measure: Secondary Efficacy against COVID-19
timeFrame: > 7 days and > 14 days after booster vaccination
measure: Secondary Safety
timeFrame: 0-30 days after booster vaccination
measure: Secondary Safety
timeFrame: within 12 months after booster vaccination
measure: Secondary Immunogenicity indicator 1
timeFrame: day 14, day 30 and 3 months after booster vaccination
measure: Secondary Immunogenicity indicator 2
timeFrame: day 14, day 30 and 3 months after booster vaccination
Other outcomes:
Locations:
Study officials:
References: