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

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Fakultas Kedokteran Universitas Padjadjaran, Fakultas Kedokteran Universitas Udayana, PT Equilab International (CRO)
No Registry
INA-B4C8H82
Tanggal Input Registry : 09-06-2022

01-09-2022
To evaluate non-inferiority of immune response of SARS-CoV2 neutralizing antibody of Bio Farma vaccine compared to control vaccine at 14 days after booster dose
To evaluate SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to control vaccine at 28 days after booster dose
 
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
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
Interventional
SARS-CoV-2 Protein Subunit Recombinant Vaccine
900
 

Inclusion Criteria:

1Clinically 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

Exclusion Criteria:

"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 within 1 month before and after IP immunization, Subjects plan to move from the study area before the end of study period"
 
No.LB.02.01/X.6.5/256/2022, No.2161/UN14.2.2.VII.14/LT/2022
Not applicable
PPUK/PPUB number
CoV2-Booster 0222
Prof. Dr. Kusnandi Rusmil, dr., SpA(K), MM, Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K)