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

NCT06272253 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: UNAIR-MP-INAKTIF-R-010
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19 Pandemic; COVID-19 Vaccines

Keywords

Inactivated COVID-1 9 Vaccine; Immunobridging Study; Immunogenicity; Safety; COVID-19; Indonesia

Outcome Measures

Primary Outcomes (1)

• Humoral Immune Response (Neutralizing antibody)

  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 Outcomes (3)

• Incidence of Adverse Events

  7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster.

• Humoral Immune Response - The neutralizing antibody

  3 and 6 months following vaccination with INAVAC vaccine as heterologue booster

• Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA

  28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster

Other Outcomes (1)

• Exploratory Endpoints-Whole Genome Sequencing

  Through study completion, an average of 6 months after the study product administration

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Subjects already received 2 (two) doses of Coronavac (Sinovac) vaccines at least 3 months prior to this study.
• Subjects and the parents or guardian have been informed properly regarding the study and signed the informed consent form
• Subject and the parents or guardian will commit to comply with the instructions of the investigator and the schedule of the trial
• Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the vaccine.
• 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.

You may not qualify if:

• Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial
• 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)
• Known history of allergy to any component of the vaccines
• History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
• Any autoimmune or immunodeficiency disease/condition
• 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.
• 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.
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
• Subjects already immunized with any other vaccines within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose
• 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.
• 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.
• History of alcohol or substance abuse
• HIV patients.
• Malignancy patients within 3 years prior to study vaccination.
• Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead
• Indonesia-MoH: collaborator
• Universitas Airlangga: collaborator
• PT Biotis Pharmaceuticals, Indonesia: collaborator

Study Sites (1)

Dr. Soetomo General Hospital

Surabaya, East Java, 67161, Indonesia

Location

Related Publications (24)

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Related Links

• New York Vaccine Tracker. Downloaded from https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine- tracker.html. Accessed 30 April 2022.
• Badan POM Republik Indonesia. Dowloaded from https://www.pom.go.id/siaran-pers/pastikan-keamanan-dan-mutu-vaksin-badan-pom-kawal-uji-klinik-vaksin-merah-putih. Accessed 11 October 2021.
• Worldometer coronavirus cases. Downloaded from https://www.worldometers.info/coronavirus/. Accessed 30 April 2022.

MeSH Terms

Conditions

COVID-19

Interventions

vaksin merah putih - UA SARS-CoV-2 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 22, 2024
• Study Start: September 19, 2023
• Primary Completion: March 19, 2024
• Study Completion: July 19, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)