COVID-19
Conditions
Keywords
COVID-19 vaccine, healthy population, Booster
Brief 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.
Detailed description
This trial is observer-blind, randomized, prospective intervention study. In this study 900 subjects who had received complete primary doses of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector (AstraZeneca®) COVID-19 vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial. Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control.
Interventions
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
BIOLOGICALActive Comparator
The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).
Sponsors
Universitas Padjadjaran
Udayana University
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Vaccine candidate and active comparator are masking.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of the candidate vaccine | 14 days after booster vaccination | Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate of the candidate vaccine | Baseline and 14 days after booster vaccination | Seroconversion rate of neutralizing antibody |
| Seropositive rate and GMT of candidate vaccine | Baseline, 14 days, and 6 months after booster vaccination | Seropositive rate and GMT of candidate vaccine |
| Seropositive rate of the candidate vaccine | Baseline, 14 days and 6 months after booster vaccination | Seropositive rate of neutralizing antibody |
| Safety of the candidate vaccine | 28 days after booster vaccination | Percentage of subjects with solicited and unsolicited Adverse Events (AE) |
| Serious Adverse Event (SAE) of the vaccine | 6 months after booster vaccination | Percentage of subjects with at least 1 SAE |
| Comparison of immunogenicity between candidate vaccine and control group | 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 |
Countries
Indonesia
Outcome results
None listed