The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018
This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above). The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
175
candidate vaccine manufactured by PT. Bio Farma
active control manufactured by Sinovac Life Sciences Co.Ltd
Faculty of Medicine, Diponegoro University, Semarang
Semarang, Central Java, Indonesia
Fakultas Kedokteran Universitas Indonesia
Jakarta, Greater Jakarta, Indonesia
Safety of the 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 vaccine within 28 days after each dose
percentage of subjects with solicited and unsolicited 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
Comparison of safety between vaccine and active control
percentage of subjects with AE and SAE between vaccine and active control group
Time frame: 28 days after each dose and 6 months after the last dose
Deviation of laboratory evaluation
Any deviation from routine laboratory evaluation that probably related to the dosing
Time frame: 7 days after the first dose and 14 days after the last dose
Inflammatory factor evaluation
The change of interleukin-6 (IL-6) in serum
Time frame: 7 days after the first dose and 14 days after the last dose
Immunogenicity profile after the last dose
GMT of IgG antibody and neutralization antibody
Time frame: 14 days and 28 days after the last dose
Immunogenicity profile after the last dose
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seroconversion rate of IgG antibody and neutralization antibody
Time frame: 14 days and 28 days after the last dose
Comparison of immunogenicity profile
GMT of IgG antibody and neutralization antibody
Time frame: 14 days and 28 days after the last dose
Comparison of immunogenicity profile
seroconversion rate of IgG antibody and neutralization antibody
Time frame: 14 days and 28 days after the last dose