Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity \& Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.
This trial is observer-blind, randomized, prospective intervention study. In this study 900 subjects who had received complete primary doses of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector (AstraZeneca®) COVID-19 vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial. Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
696
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).
Faculty of Medicine Universitas Udayana
Denpasar, Bali, Indonesia
Faculty of Medicine Universitas Padjadjaran
Bandung, West Java, Indonesia
Immunogenicity of the candidate vaccine
Geometric Mean Titer (GMT) and GMT ratio 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 and 6 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 candidate vaccine
Time frame: Baseline, 14 days, and 6 months after booster vaccination
Seroconversion rate of the candidate vaccine
Seroconversion rate of IgG antibody (RBD)
Time frame: baseline and 14 days after booster vaccination
Comparison of immunogenicity between candidate vaccine and control group
Comparison of GMT, seroconversion rate, seropositive rate of neutralizing antibody and IgG antibody (RBD) between candidate vaccine and control group
Time frame: Baseline, 14 days, and 6 months after booster vaccination
Safety of the candidate vaccine
Percentage of subjects with solicited and unsolicited Adverse Events (AE)
Time frame: 28 days after booster vaccination
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Serious Adverse Event (SAE) of the vaccine
Percentage of subjects with at least 1 SAE
Time frame: 6 months after booster vaccination