Observer-blind, randomized, active-controlled prospective intervention study
This trial is randomized, prospective intervention study. A total of 4,050 subjects (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into three study subsets, namely Main Study I, Main Study II, and Exploratory Study: Main Study I for immunogenicity and safety evaluation, Main Study II for safety evaluation, and Exploratory Study for cellular immunity evaluation, with trial design as follow : * Main Study I, Exploratory Study subset: Observer-blind, randomized, active-controlled prospective intervention study * Main Study II: Open-label, randomized study to evaluate safety I
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
4,050
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Covovax® COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 betacoronavirus
Faculty of Medicine Diponegoro University
Semarang, Central Java, Indonesia
Fakultas Kedokteran Universitas Indonesia
Jakarta, Greater Jakarta, Indonesia
Faculty of Medicine Universitas Hassanudin
Makassar, South Sulawesi, Indonesia
Faculty of Medicine Universitas Andalas
Padang, West Sumatera, Indonesia
Immunogenicity of the candidate vaccine
Geometric Mean Titers (GMT) of neutralizing antibody
Time frame: 14 days after the last dose
Seroconversion rate of the candidate vaccine
Seroconversion rate of neutralizing antibody
Time frame: 14 days after the last dose
Safety of the candidate vaccine
percentage of subjects with solicited and unsolicited Adverse Events (AE)
Time frame: 28 days after each dose
Serious Adverse Event (SAE) of the vaccine
percentage of subjects with at least 1 SAE
Time frame: 12 months after the last dose
Persistence neutralizing antibody of vaccine candidate
GMT of neutralization antibody
Time frame: 28 days, 3 months, 6 months and 12 months after the last dose
Persistence Immunoglobulin G (IgG) antibody of vaccine candidate
GMT of IgG antibody (RBD)
Time frame: 14 days, 28 days, 3 months, 6 months and 12 months after the last dose
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