NCT05226429

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)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 495 (estimated)
• Sponsor: Dr. Soetomo General Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-02-08
• Primary completion: 2023-04-06
• Completion: 2023-07-06
• First posted: 2022-02-07
• Last updated: 2023-06-15

Locations

1 site across 1 country: Indonesia