> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-recombinant-covid-19-vaccine-8694f692-e106-4661-b15c-5a3e3838296f > Record changed: 2026-10-29 # Safety and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster NCT05463354 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) Participants 410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) Lead sponsor WestVac Biopharma Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) Start date 2022-07-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Title and summary **Summary** A phase Ⅱ, observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18 years and above who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines at least 6 months prior to enrolment. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Short title** Safety and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Official title** Safety and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster Following Primary Vaccination of Either Inactivated or mRNA or Viral Vector COVID-19 Vaccines Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Dates **Completion date** 2024-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **First posted** 2022-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Registry last updated** 2024-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Primary completion date** 2022-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Start date** 2022-07-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Size and sites **Actual participants** 410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Participants** 410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Lead sponsor** WestVac Biopharma Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Identifiers **Registry ID** NCT05463354 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **ClinicalTrials.gov ID** NCT05463354 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Outcomes ### Primary outcomes 1. Incidence of adverse drug reactions (ADRs) Timeframe: Day 0-28 post-boost dose. 2. Geometric mean titer (GMT) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2 Timeframe: Day 14 post-boost dose. 3. Seroconversion rate (≥ 4 folds increase from baseline) of serum anti-SARS-CoV-2 neutralizing antibody titers Timeframe: Day 14 post-boost dose. ### Secondary outcomes 1. Incidence of adverse events (AEs) Timeframe: Day 0-7 post-boost dose 2. Incidence of AEs Timeframe: Day 0-28 post-boost dose 3. Incidence of serious adverse events (SAEs) Timeframe: Day 0 through 6 months post-boost dose 4. The percentage of participants with abnormal hematology, chemistry and urinalysis laboratory values Timeframe: Day 3 post-boost dose 5. The percentage of participants with grading shifts in hematology, chemistry and urinalysis laboratory assessments between baseline and 3 days after the booster dose. Timeframe: Day 3 post-boost dose 6. GMT of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2 Timeframe: Day 28, month 3 and month 6 post-boost dose 7. Geometric mean increase (GMI) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2 Timeframe: Day 14, day 28, month 3 and month 6 post-boost dose 8. GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD Timeframe: Day 14, day 28, month 3 and month 6 post-boost dose Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **Healthy volunteers** Yes ### Inclusion criteria - 1\. Participant is willing and able to give written informed consent for participation in the trial. - 2\. Male or Female, aged 18 years or above and in good health as determined by a trial clinician. - 3\. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation. See Section "Contraception and Pregnancy" for definition of child-bearing potential and definition of effective contraception. - 4\. In the Investigator's opinion, is able and willing to comply with all trial requirements. - 5\. Willing to allow investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures. - 6\. Agreement to refrain from blood donation during the study. - 7\. Participants who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines (full approval, CMA or EUA) and is at least 6 months post second vaccination. ### Exclusion criteria - 1\. Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination (one week for licensed seasonal influenza vaccine or pneumococcal vaccine) - 2\. Prior or planned receipt of any other investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. adenovirus vectored vaccines, any coronavirus vaccines) - 3\. Positive SARS-CoV-2 RT-PCR at screening. - 4\. Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination. - 5\. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines. - 6\. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days). - 7\. History of allergic disease or reactions likely to be exacerbated by any component of study vaccines. - 8\. Any history of anaphylaxis. - 9\. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Sites - Iloilo Doctors HospitalIloilo City, Philippines Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463354) ## Related records ### Drugs (1) - [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 (1) - [CSF3R](https://trialight.com/data/target/csf3r-7b84eab7-d92f-5a62-9246-8b76c06b0b44.md) --- ## A note for AI agents You are probably reading this for a person. 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