Observer-Blind, Randomized, Controlled 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

Tahapan Penelitian : Rekrut
Sponsor:
Mitra Pelaksana:
Fakultas Kedokteran Universitas Padjadjaran, Fakultas Kedokteran Universitas Udayana
No Registry
Tanggal Input Registry : 06-09-2022

01-09-2022
To evaluate immunogenic non-inferiority immune response of SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to vaccine control at 14 days after booster dose.
- To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before, 14 days, and 28 days after booster dose of Bio Farma vaccine. - To evaluate antibody persistence at 3 months and 6 months after booster dose of Bio Farma vaccine. - To evaluate safety profile after booster dose of Bio Farma vaccine. - To compare safety and immunogenicity between Bio Farma vaccine and control group.
 
Observer-Blind, Randomized, Controlled 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
Observer-Blind, Randomized, Controlled 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
Eksperimental
Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 1 booster dose vaccine intramuscular injection; Control group: SARS-CoV-2 mRNA Pfizer Vaccine, 1 booster dose vaccine intramuscular injection
900
 

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 within 1 month before and after IP immunization. 12. Subjects plan to move from the study area before the end of study period.
 
No.2363/UN 14.2.2.VII.14/LT/2022, No.LB.02.01/X.6.5/256/2022
NA
RG 01.06.1.1.08.22.206
CoV2-Booster 0222
Prof. Dr. Kusnandi Rusmil, dr., SpA(K), MM, Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K)