Official Title
Immunobridging Study: Immunogenicity and Safety of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia
Brief Summary

The goal of this open-label clinical trial is to evaluate the safety and immunogenicityof INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine asHomologue Booster in Adult Subjects in Indonesia. The main question it aims to answer is:"To evaluate the humoral immunogenicity profile at 28 days following vaccination withINAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18years and above". Participants will be administered one dose of vaccination for the thirddose (booster vaccination) intramuscularly.

Detailed Description

This is an open-label trial. There will be only one group in the study. This group will
receive the INAVAC vaccine as a booster. The inclusion and exclusion criteria for the
subjects are listed below. All subjects will be followed for 6 months. The vaccine will
be administered intramuscularly. This study will have one interim and one full analysis
report. A Data Safety Monitoring Board will be commissioned for this study to evaluate
safety data over the study period and to review any events that meet a specific study
pausing rule or any other safety issue that may arise. They will review the 7 and 28-day
safety data following the vaccine, and then the 3 and 6-month safety data. The
immunogenicity data will be evaluated for 6 months.

Recruiting
COVID-19 Pandemic
COVID-19 Vaccines
COVID-19 Virus Disease

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

1 dose of 0.5 ml containing inactivated SARS-CoV-2 virus (5 μg ), Tween 80, histidine,
Polysorbate 80, Aluminium hydroxide gel, and sodium chloride

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Indonesia
Locations

Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia

Investigator: Dominicus Husada, MD
Contact: ‭+6281232266377‬
dominicushusada@yahoo.com

Not Provided

Dr. Soetomo General Hospital
NCT Number
Keywords
Inactivated COVID-19 Vaccine
Immunogenicity
safety
Covid-19
Indonesia
Immunobridging Study
Booster
INAVAC
MeSH Terms
COVID-19
Virus Diseases