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UNAIR Inactivated COVID-19 Vaccine as Homologue Booster (Immunobridging Study) | Clinical Trials | Clareo Health

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

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

NCT06259578•Dr. Soetomo General Hospital

View on ClinicalTrials.gov

Summary

The goal of this open-label clinical trial is to evaluate the safety and immunogenicity of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue 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 with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above". Participants will be administered one dose of vaccination for the third dose (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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+15 more criteria

Locations (1)

Dr. Soetomo General Hospital

Surabaya, East Java, Indonesia

Key Dates

Start Date

January 29, 2024

Primary Completion Date

August 29, 2024

Completion Date

December 29, 2024

Last Updated

February 14, 2024

Enrollment

400

ESTIMATED participants

Conditions

COVID-19 PandemicCOVID-19 VaccinesCOVID-19 Virus Disease

Interventions

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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