> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-of-recombinant-covid-19-bivalent-xbb-6b1f79b9-6e5c-4ed8-adf2-3b5535c20652 > Record changed: 2026-10-13 # A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination NCT05911048 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) Participants 3,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) Lead sponsor WestVac Biopharma Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) Start date 2024-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Short title** A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Dates **Completion date** 2025-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **First posted** 2023-06-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Registry last updated** 2024-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Primary completion date** 2025-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Start date** 2024-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Size and sites **Participants** 3,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Planned participants** 3,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Lead sponsor** WestVac Biopharma Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Identifiers **Registry ID** NCT05911048 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **ClinicalTrials.gov ID** NCT05911048 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Outcomes ### Primary outcomes 1. AE and AR Timeframe: 0-7 days after vaccination Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after vaccination. 2. 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. ### Secondary outcomes 1. AE and AR Timeframe: 0-30 days post-vaccination. Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days post-vaccination. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05911048) ## Related records ### Drugs (3) - [Ecallantide](https://trialight.com/data/asset/ecallantide-69df0662-e2f8-453e-a613-6a9a354e572a.md) - [Interferon alfa-2A](https://trialight.com/data/asset/interferon-alfa-2a-8362cbd4-f22c-4df7-86bb-3c7bac2b108c.md) - [Regramostim](https://trialight.com/data/asset/regramostim-71097184-8048-4d6e-a5cc-194c86388a4e.md) ### Lead sponsors (1) - [WestVac Biopharma Co., Ltd.](https://trialight.com/data/company/westvac-biopharma-co-ltd-fa57a7f3-9053-4f67-8ea4-042d6bc1a577.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition ### Targets (4) - [CSF3R](https://trialight.com/data/target/csf3r-7b84eab7-d92f-5a62-9246-8b76c06b0b44.md) - [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md) - [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md) - [KLKB1](https://trialight.com/data/target/klkb1-1b5f36f0-03d2-539a-a1ff-0cb816e42034.md) --- ## A note for AI agents You are probably reading this for a person. 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