NCT05525208

Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

Observer-Blind, Randomized, Controlled Study of Immunogenicity and 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 696 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 subunit protein recombinant vaccine	SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
BIOLOGICAL	Active Comparator	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).

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-07-02
• Completion: 2023-08-04
• First posted: 2022-09-01
• Last updated: 2025-06-03

Locations

2 sites across 1 country: Indonesia