> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/booster-study-of-covid-19-protein-subunit-recombinant-fabfbfa3-43de-4530-9a68-db9ebb0d93c1 > Record changed: 2026-10-13 # Booster Study of COVID-19 Protein Subunit Recombinant Vaccine NCT05525208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) Participants 696 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) Lead sponsor PT Bio Farma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) Start date 2022-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Title and summary **Summary** Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity \\& Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Short title** Booster Study of COVID-19 Protein Subunit Recombinant Vaccine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Official title** Observer-Blind, Randomized, Controlled Study of Immunogenicity and Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Dates **Completion date** 2023-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **First posted** 2022-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Registry last updated** 2025-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Primary completion date** 2023-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Start date** 2022-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Size and sites **Actual participants** 696 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Participants** 696 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Lead sponsor** PT Bio Farma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Identifiers **Registry ID** NCT05525208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **ClinicalTrials.gov ID** NCT05525208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Double masking **Masking description** Vaccine candidate and active comparator are masking. **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Outcomes ### Primary outcomes 1. Immunogenicity of the candidate vaccine Timeframe: 14 days after booster vaccination Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2 ### Secondary outcomes 1. Seropositive rate of the candidate vaccine Timeframe: Baseline, 14 days and 6 months after booster vaccination Seropositive rate of neutralizing antibody 2. Seroconversion rate of the candidate vaccine Timeframe: Baseline and 14 days after booster vaccination Seroconversion rate of neutralizing antibody 3. Seropositive rate and GMT of candidate vaccine Timeframe: Baseline, 14 days, and 6 months after booster vaccination Seropositive rate and GMT of candidate vaccine 4. Seroconversion rate of the candidate vaccine Timeframe: baseline and 14 days after booster vaccination Seroconversion rate of IgG antibody (RBD) 5. Comparison of immunogenicity between candidate vaccine and control group Timeframe: Baseline, 14 days, and 6 months after booster vaccination Comparison of GMT, seroconversion rate, seropositive rate of neutralizing antibody and IgG antibody (RBD) between candidate vaccine and control group 6. Safety of the candidate vaccine Timeframe: 28 days after booster vaccination Percentage of subjects with solicited and unsolicited Adverse Events (AE) 7. Serious Adverse Event (SAE) of the vaccine Timeframe: 6 months after booster vaccination Percentage of subjects with at least 1 SAE Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Clinically healthy adults 18 years of age and older. 2. Subjects who have previously received complete primary series of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion. 3. Subjects have been informed properly regarding the study and signed the informed consent form. 4. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial. ### Exclusion criteria 1. Subject concomitantly enrolled or scheduled to be enrolled in another trial. 2. Subject who has received booster dose of COVID-19 vaccine. 3. Subject who has history of COVID-19 in the last 3 months (based on anamnesis or other examinations). 4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 5. Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 6. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 8. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives. 9. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)). 10. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome. 11. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization. 12. Subjects plan to move from the study area before the end of study period. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Sites - Faculty of Medicine Universitas UdayanaDenpasar, Indonesia - Faculty of Medicine Universitas PadjadjaranBandung, Indonesia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05525208) ## Related records ### Drugs (2) - [Adintrevimab](https://trialight.com/data/asset/adintrevimab-54fe54a2-887b-412b-94e4-d15b7c142b42.md) - [Meropenem](https://trialight.com/data/asset/meropenem-a90880e5-37b0-473b-bf12-d5f0de7894c2.md) ### Collaborators (2) - Udayana University - Universitas Padjadjaran ### Lead sponsors (1) - [PT Bio Farma](https://trialight.com/data/company/pt-bio-farma-42be2c17-f22a-46e5-8a73-fb239c6d39df.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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