INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old

February 21, 2024 updated by: Dr. Soetomo General Hospital

An Open Label, Phase III Clinical Trial (Immunobridging Study) of INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated)) in Healthy Population Aged 12 to 17 Years Old

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.

INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.

This study will have three interim and one full analysis The main focus is immunogenicity and safety or reactogenicity issues.

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 days safety data following the first dose of vaccine, and then the 7 and 28 days after the second dose. The immunogenicity data will be evaluated until 12 months after the second dose.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • Jawa Timur
      • Surabaya, Jawa Timur, Indonesia, 67161
        • Recruiting
        • Dr. Soetomo General Hospital
        • 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:
          • Maria I Lusida, MD
        • Sub-Investigator:
          • Eko B Khoendori, MD
        • Sub-Investigator:
          • Neneng D Kurniati, MD
        • Sub-Investigator:
          • Budi Utomo, MD
        • Sub-Investigator:
          • Novira Widajanti, MD
        • Sub-Investigator:
          • Laksmi Wulandari, MD
        • Sub-Investigator:
          • Fitriah Munawaroh, MD
        • Sub-Investigator:
          • Jusak Nugroho, 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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy adolescents, age 12 to 17 years old, males and females. 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 and the parents or guardians have been informed properly regarding the study and signed the informed consent and assent forms
  3. Subject and the parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial
  4. 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.
  5. Subjects and the parents or guardians 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 vaccine trial
  2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5oC or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptms 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 steroid will be permitted.
  7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator.
  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 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) 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 test or, if necessary, PCR test) 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. Alcohol or substance abuse
  14. HIV patients.
  15. Malignancy patients within 2 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 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.

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: Experimental:

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

Study product are provided in the form of liquid in vial single dose (0.5 ml). The vaccine will be given 1 dose (0.5 ml) twice.
Biological: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg
Dose : 1 dose 0.5 ml containing 5 µg inactivated SARS-CoV-2 virus, 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
Vaccine Neutralizing Antibody Profile
Time Frame: 28 days after two doses vaccination of INAVAC.
SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days after two doses vaccination of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).
28 days after two doses vaccination of INAVAC.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: 30 minutes, 24 hours, 7 and 28 days following the first dose and 30 minutes, 24 hours, 7 and 28 days, 3, 6 and 12 months after the second doses of INAVAC
  1. Solicited - clinical (local and systemic) adverse events for 30 minutes, 24 hours, 7 and 28 days after the first and second vaccination, and then 3, 6, and 12 months after the second injection of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).
  2. Unsolicited adverse events for 30 minutes, 24 hours, 7 and 28 days after the first and second vaccination, and then 3, 6, and 12 months after the second injection of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).
  3. Serious adverse event (SAE) throughout the study (from the first vaccination).
30 minutes, 24 hours, 7 and 28 days following the first dose and 30 minutes, 24 hours, 7 and 28 days, 3, 6 and 12 months after the second doses of INAVAC
Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum
Time Frame: 3, 6, and 12 months, following vaccination with two doses of INAVAC
Evaluate SARS-Cov-2 neutralizing titers in serum measured by virus neutralization assay at 3, 6, and 12 months, following vaccination with two doses of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).
3, 6, and 12 months, following vaccination with two doses of INAVAC
Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA
Time Frame: 28 days, 3, 6, and 12 months after the second vaccination of INAVAC
SARS-CoV-2 binding antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein.
28 days, 3, 6, and 12 months after the second vaccination of INAVAC
Cellular Immunogenicity Profile
Time Frame: 28 days, 3, 6, and 12 months, following vaccination with two doses of INAVAC
  1. Th1 immune responses assessed by Flow cytometri
  2. Th2 immune responses assessed by Flow cytometri
28 days, 3, 6, and 12 months, following vaccination with two doses of INAVAC
Persistence of Antibody Level
Time Frame: 12 months after the second injection
Evaluate the persistence of antibody level over time for 12 months after second injection.
12 months after the second injection
Whole Genome Sequencing (WGS) of SARS-CoV-2
Time Frame: Throughout the study, an average of 1 year
Whole genome sequencing (WGS) of S protein of SARS-CoV-2 virus from all positive Covid-19 cases
Throughout the study, an average of 1 year

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
PT Biotis Pharmaceuticals, Indonesia

Investigators

  • Principal Investigator: Dominicus Husada, MD, Dr. Soetomo General Hospital

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

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)

June 19, 2023

Primary Completion (Estimated)

May 19, 2024

Study Completion (Estimated)

July 19, 2024

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Estimated)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 21, 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-R-005

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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