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UNAIR Inactivated COVID-19 Vaccine | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

UNAIR Inactivated COVID-19 Vaccine

Safety and Immunogenicity of UNAIR Inactivated COVID-19 Vaccine in Healthy Populations Aged 18 Years and Above (Phase I/II)

NCT05226429•Dr. Soetomo General Hospital

View on ClinicalTrials.gov

Summary

This is a randomized, observer blind, controlled phase I/II study to evaluate the Safety, Reactogenicity, and Immunogenicity of UNAIR Inactivated Covid-19 Vaccine in Healthy Populations Aged 18 Years and Above. UNAIR Inactivated Covid-19 Vaccine is an inactivated vaccine developed by Airlangga University (Universitas Airlangga / UNAIR) made of SARS-CoV-2 virus isolated from a patient in Surabaya, Indonesia, composed with aluminium hydroxy gel, tween 80, and L-histidine. This study will be the first in human.

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 have been informed properly regarding the study and signed the informed consent form
•3. Subject will commit to comply with the instructions of the investigator and the schedule of the trial
•4. Female subjects of childbearing potential must agree to consistently use any methods of contraception (except the periodic abstinence) from at least 21 days prior to enrollment and through 6 months after the last vaccination.
•5. 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.
•6. Participants 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 trial.
•2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior to first 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 has 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 is prohibited.
•7. Chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine
•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
+15 more criteria

Locations (1)

Dr. Soetomo General Hospital

Surabaya, East Java, Indonesia

Key Dates

Start Date

February 8, 2022

Primary Completion Date

April 6, 2023

Completion Date

July 6, 2023

Last Updated

June 15, 2023

Enrollment

495

ESTIMATED participants

Conditions

COVID-19 PandemicVaccine Reaction

Interventions

UNAIR Inactivated COVID-19 Vaccine

BIOLOGICAL

CoronaVac Biofarma COVID-19 Vaccine

BIOLOGICAL

Contacts

Dominicus Husada, MD

CONTACT

‭+6281232266377‬dominicushusada@yahoo.com

Damayanti Tinduh, MD

CONTACT

‭+6281703293335‬damayanti.tinduh@fk.unair.ac.id

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COVID-19 PneumoniaCOVID-19 Pandemic+1 more

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RECRUITINGNA

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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: June 15, 2023Data 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

Inclusion Criteria

Exclusion Criteria

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