UNAIR Inactivated COVID-19 Vaccine for Healthy Adults

Safety and Immunogenicity of UNAIR Inactivated COVID-19 Vaccine in Healthy Populations Aged 18 Years and Above (Phase I/II)

This study is testing a new COVID-19 vaccine for healthy adults to see if it is safe and effective compared to another vaccine.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 495 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dr. Soetomo General Hospital (Government)
• Locations: 1 site (Surabaya, East Java)
• Trial ID: NCT05226429 on ClinicalTrials.gov

What this trial studies

This is a randomized, observer-blind, controlled phase I/II evaluation of the UNAIR Inactivated COVID-19 Vaccine, designed to assess its safety, reactogenicity, and immunogenicity in healthy individuals aged 18 and older. The vaccine is developed by Airlangga University using an inactivated form of the SARS-CoV-2 virus isolated from a patient in Surabaya, Indonesia. Participants will receive either the UNAIR vaccine or the CoronaVac Biofarma vaccine, and the study aims to determine the vaccine's effectiveness and safety profile in a controlled setting.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 years and older who meet specific health criteria.

Not a fit: Patients with underlying health conditions or those who are not healthy as determined by the investigator may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a new option for preventing COVID-19, particularly in Indonesia.

How similar studies have performed: Other studies on inactivated COVID-19 vaccines have shown promising results, indicating potential for success with this approach.

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 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.

Where this trial is running

Surabaya, East Java

• Dr. Soetomo General Hospital — Surabaya, East Java, Indonesia (Recruiting)

Study contacts

• Principal investigator: Dominicus Husada, MD — Dr. Soetomo General Hospital
• Study coordinator: Dominicus Husada, MD

Conditions COVID-19 Pandemic; Vaccine Reaction; Inactivated COVID-19 Vaccine; Immunogenicity; Indonesia; COVID-19