Open-label, prospective intervention study of IndoVac® as a single, homologous boosterdose
This trial is open-label, prospective intervention study. A total of 150 subjects who had
previously received complete primary doses of IndoVac® in phase III and are willing to
participate in the study by signing the consent form, will be involved in this trial. The
regimen of the vaccine 0.5 ml injected as a single booster dose.
Evaluation will be conducted for safety and immunogenicity for all subjects. Safety
evaluation include AEs until 28 days post booster dose, with AESIs and SAEs throughout
the trial. Immunogenicity evaluation will compare pre-booster antibody titer (baseline)
to post- booster antibody titer at 14 days, 28 days, 3 months, 6 months, and 12 months
timepoint. Interim evaluation will be performed at 14 days post booster dose for
Emergency Use Authorization (EUA) consideration. All subjects will be followed up until
12 months post booster dose.
Biological: SARS-CoV-2 Subunit Recombinant Protein Vaccine
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT Bio Farma
Inclusion Criteria:
1. Clinically healthy subjects aged 18 years and above.
2. Subjects had previously received complete primary doses of IndoVac® with the last
dose administered minimum 12 months but no longer than 18 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. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. Subjects had received booster dose of COVID-19 vaccine.
3. History of COVID-19 within 3 months prior to enrollment (based on anamnesis or other
examinations).
4. Evolving mild, moderate, or severe illness, especially infectious disease, or fever
(body temperature ≥37.5°C, 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 uncontrolled asthma, 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 or diabetes, liver or kidney diseases, malignant tumors,
etc.) which according to the investigator might interfere with the assessment of the
trial objectives.
9. History of confirmed or suspected immunosuppressive or immunodeficient state or in
the previous 4 weeks had received a treatment likely to alter the immune response
(intravenous immunoglobulins, blood-derived products, or long- term corticosteroid
therapy (> 2 weeks)).
10. History of uncontrolled epilepsy or other progressive neurological disorders, such
as Guillain- Barre Syndrome.
11. Subjects had received any vaccination (other than COVID-19 vaccine) within 1 month
before IP immunization.
12. Subjects plan to move from the study area before the end of study period.
Not Provided
Rini M. Sari, MD
+6222-2033755 - 5045
rini.mulia@biofarma.co.id
Yetty Movieta Nency, MD, Principal Investigator
Faculty of Medicine Universitas Diponegoro