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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
495
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.
Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia.
Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia
RECRUITINGSolicited clinical (local and systemic), laboratory, and unsolicited adverse events
The number of adverse events occur among participants.
Time frame: 7 days each vaccination
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events
The number of adverse events occur among participants.
Time frame: 28 days after each vaccination
SARS-CoV-2 neutralization antibodies
The level of SARS-CoV-2 neutralization antibodies in participants.
Time frame: 28 days after the second vaccination
SARS-CoV-2 binding antibodies
The level of SARS-CoV-2 binding antibodies in participants.
Time frame: 28 days after the second vaccination
Th1 and Th2
Th1 and Th2 levels in participants.
Time frame: 28 days after the second vaccination
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events
The number of adverse events occur among participants.
Time frame: 3, 6, and 12 months after the first vaccination
SARS-CoV-2 neutralization antibodies
The level of SARS-CoV-2 neutralization antibodies in participants.
Time frame: 3, 6, and 12 months after the first vaccination
SARS-CoV-2 binding antibodies
The level of SARS-CoV-2 binding antibodies in participants.
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Time frame: 3, 6, and 12 months after the first vaccination
Th1 and Th2
Th1 and Th2 levels in participants.
Time frame: 3, 6, and 12 months after the first vaccination