Observer-blind, randomized, active-controlled prospective intervention study ofImmunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) asa Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.
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.
Biological: SARS-CoV-2 subunit protein recombinant vaccine
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Biological: Active 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).
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.
Faculty of Medicine Universitas Udayana
Denpasar, Bali, Indonesia
Faculty of Medicine Universitas Padjadjaran
Bandung, West Java, Indonesia
Rini M. Sari, MD
+6222-2033755
rini.mulia@biofarma.co.id
Kusnandi Rusmil, Prof, MD, Principal Investigator
Faculty of Medicine Universitas Padjadjaran