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UNAIR Inactivated COVID-19 Vaccine

NCT05226429 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2023-06-15

No results posted yet for this study

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.

Conditions

  • COVID-19 Pandemic
  • Vaccine Reaction

Interventions

BIOLOGICAL

UNAIR Inactivated COVID-19 Vaccine

UNAIR Inactivated Covid-19 Vaccine contains S protein of SARS-CoV-2 virus, Aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005% Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). One vial will be used for one injection only. The vial should be shaken well before injection.

BIOLOGICAL

CoronaVac Biofarma COVID-19 Vaccine

Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia.

Sponsors & Collaborators

  • Indonesia-MoH

    collaborator OTHER_GOV

  • Universitas Airlangga

    collaborator OTHER

  • Bioxis Pharmaceuticalls

    collaborator INDUSTRY

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Principal Investigators

  • Dominicus Husada, MD · Dr. Soetomo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2023-04-06
Completion
2023-07-06

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226429 on ClinicalTrials.gov