Evaluating a COVID-19 vaccine booster in healthy adults

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

This study is testing a COVID-19 vaccine booster to see how safe it is and how well it works in healthy adults who have already had two doses of the same vaccine.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dr. Soetomo General Hospital (other gov)
• Locations: 1 site (Surabaya, East Java)
• Trial ID: NCT06259578 on ClinicalTrials.gov

What this trial studies

This open-label clinical trial aims to assess the safety and immunogenicity of the INAVAC vaccine as a homologous booster in healthy adults aged 18 and above in Indonesia. Participants will receive one dose of the vaccine intramuscularly, and their immune response will be monitored for 6 months following vaccination. The study includes a single group of subjects who have previously received two doses of the INAVAC vaccine, with safety data reviewed at multiple intervals. A Data Safety Monitoring Board will oversee the safety aspects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 years and older who have previously received two doses of the INAVAC vaccine.

Not a fit: Patients who have not received the INAVAC vaccine or those with underlying health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance immunity against COVID-19 through an effective booster vaccination.

How similar studies have performed: Other studies have shown promising results with similar booster approaches, indicating potential for success in this trial.

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.

Where this trial is running

Surabaya, East Java

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

Conditions: COVID-19 Pandemic, COVID-19 Vaccines, COVID-19 Virus Disease, Inactivated COVID-19 Vaccine, Immunogenicity, Safety, COVID-19, Indonesia