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

Launched by DR. SOETOMO GENERAL HOSPITAL · Feb 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into the safety and effectiveness of a vaccine called INAVAC, which is designed to boost immunity against COVID-19. Specifically, the study will see how well this vaccine works as a third dose (or booster) for adults aged 18 and older who have already received two doses of the same vaccine. Participants will receive one shot of the INAVAC vaccine and will be monitored for 28 days to assess their immune response.

To be eligible for this study, participants must be healthy adults who have previously received two doses of the INAVAC vaccine, with a gap of 12 to 18 months since their last dose. They should not have any significant health issues, recent illnesses, or allergies to vaccine components. Women who can get pregnant must agree to avoid pregnancy during the study. Participants will need to attend regular check-ins and follow the study guidelines. Overall, this trial aims to help researchers understand how well the INAVAC vaccine can boost immunity in individuals who have already been vaccinated.

Gender

ALL

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.