The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.
This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above). The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
intramuscular injection
intramuscular injection
Fakultas Kedokteran Universitas Indonesia
Jakarta, Greater Jakarta, Indonesia
Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose
percentage of subjects with solicited and unsolicited Adverse Events (AE)
Time frame: 7 days after each dose
safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose
percentage of subjects with solicited and unsolicited AE
Time frame: 28 days after each dose
Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control
percentage of subjects with AE and SAE between vaccine and active control group
Time frame: 28 days after each dose
Deviation of laboratory evaluation
Any deviation from routine laboratory evaluation that probably related to the dosing
Time frame: 28 days after the first dose
Deviation of laboratory evaluation
Any deviation from routine laboratory evaluation that probably related to the dosing
Time frame: 7 days after whole schedule dose
Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose
seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody
Time frame: 28 days after each dose
Comparison of immunogenicity between 2 and 3 doses
seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody
Time frame: 28 days after second and third dose
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