A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination
- Summary
- A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination to evaluate safety and immunogenicity in healthy population aged 18 years old and above.
- Short title
- A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination
- Official title
- A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) in Booster Vaccination in Healthy Population 18 Years Old of Age and Above
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-12-30
- First posted
- 2023-06-20
- Registry last updated
- 2024-07-25
- Primary completion date
- 2025-06-30
- Start date
- 2024-12-30
- Participants
- 3,100
- Participant count basis
- Estimated
- Planned participants
- 3,100
- Protocol amendments
- Registry sponsor category
- Industry
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05911048
- ClinicalTrials.gov ID
- NCT05911048
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masked roles
- Participants, Investigators
AE and AR
Timeframe: 0-7 days after vaccination
Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after vaccination.
Primary Immunogenicity indicator
Timeframe: day 14 post-vaccination
The geometric mean titer (GMT) and seroconversion of neutralizing antibodies (true virus or pseudovirus method) against the current variants of SARS-CoV-2 (such as XBB and its subtypes) at day 14 post-vaccination.
AE and AR
Timeframe: 0-30 days post-vaccination.
Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days post-vaccination.
SAE and AE
Timeframe: within12 months post-vaccination.
Incidence of serious adverse events (SAE) and adverse events of specific interest (AESI) within 12 months post-vaccination.
Secondary Immunogenicity indicator 1
Timeframe: day 14 post-vaccination.
Geometric mean titer (GMT) and seroconversion rate of neutralizing antibody (true virus or pseudovirus method) against SARS-CoV-2 prototype strain and Omicron BA.2 variant strain on day 14 post-vaccination.
Secondary Immunogenicity indicator 2
Timeframe: day 14 post-vaccination
Geometric mean fold increase (GMI) of neutralizing antibodies against SARS-CoV-2 prototype strains, current variants (such as XBB and its subtypes), and Omicron BA.2 variants (true virus or pseudovirus method) on day 14 post-vaccination.
Secondary Immunogenicity indicator 3
Timeframe: day 30 post-vaccination.
Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) against SARS-CoV-2 prototype strains, current variants (such as XBB and its subtypes) and Omicron BA.2 variants neutralizing antibodies (true virus or pseudovirus method) at day 30 post-vaccination.
Secondary Immunogenicity indicator 4
Timeframe: 14 and 30 days post-vaccination.
Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific binding antibodies at 14 and 30 days after vaccination.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization.
- Abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine.
- 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.
Related records
Drugs (3)
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition