UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects

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

Immunobridging Study: Immunogenicity and Safety of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) as Heterologue Booster in Adolescent Subjects in Indonesia

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.

The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.

The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports.

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 vaccine, and then the 3 and 6 months safety data. The immunogenicity data will be evaluated until 6 months.

Study Type

Interventional

Enrollment (Actual)

250

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
    • Jawa Timur
      • Surabaya, Jawa Timur, Indonesia, 67161
        • Dr. Soetomo General Hospital

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 males and females, adolescents age 12-17 years old. 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 Coronavac (Sinovac) vaccines at least 3 months prior to this study.
  3. Subjects and the parents or guardian have been informed properly regarding the study and signed the informed consent form
  4. Subject and the parents or guardian will commit to comply with the instructions of the investigator and the schedule of the trial
  5. Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the vaccine.
  6. Participants and the parents or guardian 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 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. Inhaled glucocorticoids are prohibited.
  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. Subjects already immunized with any other vaccines within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose
  10. 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.
  11. Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to the 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.
  12. History of alcohol or substance abuse
  13. HIV patients.
  14. Malignancy patients within 3 years prior to study vaccination.
  15. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
  16. 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.
  17. Women who are pregnant or who plan to become pregnant during the study.
  18. Participant has major psychiatric problem or illness
  19. Participant cannot communicate reliably with the investigator
  20. Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia.
  21. 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 vaccination.
  22. 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
  23. Study team members.
  24. 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: 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) once.
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
Humoral Immune Response (Neutralizing antibody)
Time Frame: 28 days after the booster vaccination
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 heterologue booster in healthy adolescents age 12-17 years old.
28 days after the booster vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster.
  1. Solicited - clinical (local and systemic) adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy adolescents age 12-17 years old.
  2. Unsolicited adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy adolescents age 12-17 years old.
  3. Serious adverse events (SAE) throughout the study.
7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster.
Humoral Immune Response - The neutralizing antibody
Time Frame: 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster
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 heterologue booster administered intramuscularly in healthy Adolescent subjects.
3 and 6 months following vaccination with INAVAC vaccine as heterologue booster
Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA
Time Frame: 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster
IgG RBD SARS-CoV-2 (CLIA): analysis of IgG RBD SARS-CoV-2 antibodies for 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy Adolescent subjects.
28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Endpoints-Whole Genome Sequencing
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
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
PT 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)

September 19, 2023

Primary Completion (Estimated)

March 19, 2024

Study Completion (Estimated)

July 19, 2024

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Estimated)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 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-010

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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