UNAIR Inactivated COVID-19 Vaccine

ABSTRACT

ConditionCOVID-19 Pandemic;Vaccine Reaction

InterventionBiological UNAIR Inactivated COVID-19 Vaccine;Biological CoronaVac Biofarma COVID-19 Vaccine

Primary outcome:Solicited clinical (local and systemic), laboratory, and unsolicited adverse events;Solicited clinical (local and systemic), laboratory, and unsolicited adverse events;SARS-CoV-2 neutralization antibodies;SARS-CoV-2 binding antibodies;Th1 and Th2

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 have been informed properly regarding the study and signed the informed
consent form

3. Subject will commit to comply with the instructions of the investigator and the
schedule of the trial

4. Female subjects of childbearing potential must agree to consistently use any methods
of contraception (except the periodic abstinence) from at least 21 days prior to
enrollment and through 6 months after the last vaccination.

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

6. Participants must be willing to provide verifiable identification, has 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 trial.

2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever
(axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior
to first 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 has 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 steroid will be permitted. Inhaled glucocorticoids is prohibited.

7. Chronic disease, inclusive of uncontrolled hypertension, congestive heart failure,
chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring
use of medicine

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

9. Individuals who previously receive any vaccines against Covid-19

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

11. Individuals who have a previously ascertained Covid-19 in the period of 3 months
before the first recruit of this study, or in a close contact in the last 14 days with
confirmed case of Covid-19

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

13. History of alcohol or substance abuse

14. HIV patients.

15. Malignancy patients within 5 years prior to first 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, breastfeeding, or who plan to become pregnant during the
study.

19. Participant has major psychiatric problem or illness

20. Participant cannot communicate reliably with the investigator

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

22. Participant had major surgery within 12 weeks before vaccination which will not be
fully recovered, or has major surgery planned during the time 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 study period.