This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above
The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses. One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
candidate vaccine manufactured by PT. Bio Farma
the placebo is NaCl injection manufactured by PT. Bio Farma
Faculty of Medicine, Diponegoro University, Semarang
Semarang, Central Java, Indonesia
Faculty of Medicine Universitas Hassanudin
Makassar, South Sulawesi, Indonesia
Faculty of Medicine, Universitas Andalas, Padang
Padang, West Sumatera, Indonesia
Immunogenicity of the candidate vaccine
seroconversion rate of antibody (IgG and neutralization 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: 6 months after the last dose
Persistence antibody of vaccine candidate
GMT of antibody (IgG and neutralization antibody)
Time frame: 14 days, 28 days, 3 months, 6 months after the last dose
Persistence antibody of vaccine candidate
seropositive rate of antibody (IgG and neutralization antibody)
Time frame: 14 days, 28 days, 3 months, 6 months after the last dose
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