UNAIR Inactivated COVID-19 Vaccine as Homologue Booster (Immunobridging Study)

ABSTRACT

ConditionCOVID-19 Pandemic;COVID-19 Vaccines;COVID-19 Virus Disease

InterventionBiological INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 µg

Primary outcome:Humoral Immune Reponse

Criteria
Inclusion Criteria

1. Healthy adults and elderly, males and females, 18 years of age and above. Healthy
status will be determined by the investigator based on medical history, clinical
laboratory results, vital sign measurements, and physical examination at screening.

2. Subjects already received 2 (two) doses of INAVAC vaccines (5 ug), mostly during the
phase I/II/III clinical trial of this vaccine. The interval between the second primary
injection and the booster is 12-18 months.

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

5. Female subjects of childbearing potential must agree to postpone pregnancy from at
least 21 days before enrollment and through 6 months after the vaccination.

6. Participants agree not to donate bone marrow, blood, and blood products from the first
study vaccine administration until 3 months after receiving the vaccine.

7. Participants must be willing to provide verifiable identification, have means to be
contacted and to contact the investigator during the study.

Exclusion Criteria

1. Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial

2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever
(axillary temperature 37.5oC or more) concurrently or within 7 days before study
vaccination. This includes respiratory or constitutional symptoms consistent with
SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)

3. Known history of allergy to any component of the vaccines

4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular
injection

5. Any autoimmune or immunodeficiency disease/condition

6. Subjects who have received in the previous 4 weeks a treatment likely to alter the
immune response (intravenous immunoglobulin, blood-derived products, long-term
corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for
immunosuppressive treatment within 6 months after last vaccination. The use of topical
or nasal steroids will be permitted. Inhaled glucocorticoids are prohibited.

7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart
failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, and
diabetes requiring the use of medicine. The final decision regarding this condition
will be made by the attending field clinicians or investigators.

8. Any abnormality or chronic disease which according to the investigator might interfere
with the assessment of the trial objectives

9. Individuals who previously received any vaccines against Covid-19, other than INAVAC.

10. Subjects already immunized with any other vaccines within 4 weeks prior and expect to
receive other vaccines within 60 days following the booster dose

11. Individuals who have a previously ascertained COVID-19 in 1 month (for mild, moderate,
or asymptomatic people) or 3 months (for severe COVID-19) before the first recruit of
this study, or in close contact in the last 14 days with a confirmed case of Covid-19.

12. Positive test for SARS-CoV-2 (Antigen or PCR) at screening before the vaccination.
Testing may be repeated during the screening period if exposure to a positive
confirmed case of SARS-CoV-2 is suspected, at the discretion of the investigator.

13. History of alcohol or substance abuse

14. HIV patients.

15. Malignancy patients within 3 years before study vaccination.

16. Any neurological disease or history of significant neurological disorder such as
meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc

17. Vital sign abnormalities and clinical laboratory abnormalities as decided by the
investigators. Vital sign measurements and clinical laboratory testing may be repeated
before the final decision.

18. Women who are pregnant or who plan to become pregnant during the study.

19. Participant has a major psychiatric problem or illness

20. Participant cannot communicate reliably with the investigator

21. Participant has contraindications to intramuscular injection and blood draws, such as
bleeding disorders or phobia.

22. The participant had major surgery within 12 weeks before vaccination which will not be
fully recovered, or has major surgery planned during the time the participant is
expected to participate in the study or within 6 months after the last dose of study
vaccine administration.

23. Any condition that in the opinion of the investigators would pose a health risk to the
subject if enrolled or could interfere with the evaluation of the vaccine or
interpretation of the study results

24. Study team members.

25. Subject planning to move from the study area before the end of the study period.