Booster Study of COVID-19 Protein Subunit Recombinant Vaccine
- 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.
- Short title
- Booster Study of COVID-19 Protein Subunit Recombinant Vaccine
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2023-08-04
- First posted
- 2022-09-01
- Registry last updated
- 2025-06-03
- Primary completion date
- 2023-07-02
- Start date
- 2022-09-01
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- PT Bio Farma
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05525208
- ClinicalTrials.gov ID
- NCT05525208
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masking description
- Vaccine candidate and active comparator are masking.
- Masked roles
- Participants, Investigators
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
Seropositive rate of the candidate vaccine
Timeframe: Baseline, 14 days and 6 months after booster vaccination
Seropositive rate of neutralizing antibody
Seroconversion rate of the candidate vaccine
Timeframe: Baseline and 14 days after booster vaccination
Seroconversion rate of neutralizing antibody
Seropositive rate and GMT of candidate vaccine
Timeframe: Baseline, 14 days, and 6 months after booster vaccination
Seropositive rate and GMT of candidate vaccine
Seroconversion rate of the candidate vaccine
Timeframe: baseline and 14 days after booster vaccination
Seroconversion rate of IgG antibody (RBD)
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
Safety of the candidate vaccine
Timeframe: 28 days after booster vaccination
Percentage of subjects with solicited and unsolicited Adverse Events (AE)
Serious Adverse Event (SAE) of the vaccine
Timeframe: 6 months after booster vaccination
Percentage of subjects with at least 1 SAE
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- Clinically healthy adults 18 years of age and older.
- 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.
- Subjects have been informed properly regarding the study and signed the informed consent form.
- Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
- Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- Subject who has received booster dose of COVID-19 vaccine.
- Subject who has history of COVID-19 in the last 3 months (based on anamnesis or other examinations).
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- 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.
- 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)).
- Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
- Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
- Subjects plan to move from the study area before the end of study period.
- Faculty of Medicine Universitas UdayanaDenpasar, Indonesia
- Faculty of Medicine Universitas PadjadjaranBandung, Indonesia
Related records
Drugs (2)
Collaborators (2)
- Udayana University
- Universitas Padjadjaran
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition