Open-label, prospective intervention study of IndoVac® as a single, homologous booster dose
This trial is open-label, prospective intervention study. A total of 150 subjects who had previously received complete primary doses of IndoVac® in phase III and are willing to participate in the study by signing the consent form, will be involved in this trial. The regimen of the vaccine 0.5 ml injected as a single booster dose. Evaluation will be conducted for safety and immunogenicity for all subjects. Safety evaluation include AEs until 28 days post booster dose, with AESIs and SAEs throughout the trial. Immunogenicity evaluation will compare pre-booster antibody titer (baseline) to post- booster antibody titer at 14 days, 28 days, 3 months, 6 months, and 12 months timepoint. Interim evaluation will be performed at 14 days post booster dose for Emergency Use Authorization (EUA) consideration. All subjects will be followed up until 12 months post booster dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
150
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT Bio Farma
Faculty of Medicine Diponegoro University
Semarang, Central Java, Indonesia
Neutralizing antibody before and at 14 days after booster dose
Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 neutralizing antibody against Omicron variant
Time frame: Baseline, 14 days after booster dose
Neutralizing antibody at 28 days after booster dose
Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 neutralizing antibody against Omicron variant
Time frame: Baseline, 14 days, 28 days after booster dose
RBD-binding IgG antibody before, at 14 days and 28 days after booster dose
Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 RBD-binding IgG antibody
Time frame: Baseline, 14 days, 28 days after booster dose
Antibody persistence at 3, 6, and 12 months after booster dose
Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 RBD-binding IgG antibody
Time frame: Baseline, 3 months, 6 months, 12 months after booster dose
Safety after booster dose
Number and percentage of subjects with solicited and unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Time frame: Baseline to 12 months after booster dose
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