The goal of this clinical trial is to evaluate immune response and safety of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac) as a heterologous booster dose in healthy children 12-17 years of age. Participants who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine will be given IndoVac as a booster dose.
This trial is open label prospective intervention study. In this study 150 subjects who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial. Subject will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac).
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 Universitas Padjadjaran
Bandung, West Java, Indonesia
Immunogenicity of the candidate vaccine
Geometric Mean Titer (GMT) and GMFR of neutralizing antibody to the SARS-CoV-2
Time frame: 14 days after booster vaccination
Seropositive rate of the candidate vaccine
Seropositive rate of neutralizing antibody
Time frame: baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination
Seroconversion rate of the candidate vaccine
Seroconversion rate of neutralizing antibody
Time frame: baseline and 14 days after booster vaccination
Seropositive rate and GMT of candidate vaccine
Seropositive rate and GMT of IgG antibody (RBD)
Time frame: baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination
Seroconversion rate of candidate vaccine
Seroconversion rate of IgG antibody (RBD)
Time frame: baseline and 14 days after booster vaccination
Safety of the candidate vaccine
Percentage of subjects with solicited and unsolicited Adverse Events (AE)
Time frame: 30 minutes, 7 days, 28 days, and until 12 months after booster vaccination
Serious Adverse Event (SAE) of the vaccine
Percentage of subjects with at least 1 SAE
Time frame: until 12 months after booster vaccination
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