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

February 13, 2024 updated by: Dr. Soetomo General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 67161
        • Recruiting
        • Dr. Soetomo General Hospital
        • Sub-Investigator:
          • Dwiyanti Puspitasari, MD
        • Sub-Investigator:
          • Yudi H Oktaviano, MD
        • Sub-Investigator:
          • Deasy Fetarayani, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dominicus Husada, MD
        • Sub-Investigator:
          • Damayanti Tinduh, MD
        • Sub-Investigator:
          • Gatot Soegiarto, MD
        • Sub-Investigator:
          • Leny Kartina, MD
        • Sub-Investigator:
          • Aryati Aryati, MD
        • Sub-Investigator:
          • Jusak Nugraha, MD
        • Sub-Investigator:
          • Munawaroh Fitriah, MD
        • Sub-Investigator:
          • Maria I Lusida, MD
        • Sub-Investigator:
          • Eko B Khoendori, MD
        • Sub-Investigator:
          • Neneng D Kurniati, MD
        • Sub-Investigator:
          • Fierly Hayati, MD
        • Sub-Investigator:
          • Budi Utomo, MD
        • Sub-Investigator:
          • Novira Widajanti, MD
        • Sub-Investigator:
          • Laksmi Wulandari, MD
        • Sub-Investigator:
          • Fauqa A Aulia, MD
        • Sub-Investigator:
          • Andy Darma, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 μg
The study product is provided in the form of liquid in vial single dose (0.5 ml). The vaccine will be given 1 dose (0.5 ml) once.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humoral Immune Reponse
Time Frame: 28 days following vaccination
  1. SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above
  2. IgG RBD SARS-CoV-2 antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above
28 days following vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: 7 days, 28 days, 3 months and 6 months following vaccination
  1. Solicited - clinical (local and systemic) adverse events for 7 and 28 days, 3 and 6 month following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above
  2. Unsolicited adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above
  3. Serious adverse event (SAE) throughout the study
7 days, 28 days, 3 months and 6 months following vaccination
Humoral Immune Reponse
Time Frame: 3 and 6 months following vaccination
  1. SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, for 3 and 6 months following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above
  2. IgG RBD SARS-CoV-2 antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein, for 3 and 6 months following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above
3 and 6 months following vaccination
Exploratory Endpoints
Time Frame: Through study completion, an average of 6 months after the study product administration
Whole genome sequencing (WGS) of S protein of SARS-CoV-2 virus from positive Covid-19 cases during the study
Through study completion, an average of 6 months after the study product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Soetomo General Hospital

Collaborators

Indonesia-MoH
Universitas Airlangga
Biotis Pharmaceuticals, Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Estimated)

August 29, 2024

Study Completion (Estimated)

December 29, 2024

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNAIR-MP-INAKTIF-BO-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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