NCT05313035

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above

Detailed description

The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses. One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 protein subunit recombinant vaccine	candidate vaccine manufactured by PT. Bio Farma
BIOLOGICAL	placebo	the placebo is NaCl injection manufactured by PT. Bio Farma

Timeline

• Start date: 2022-04-13
• Primary completion: 2022-07-22
• Completion: 2023-02-28
• First posted: 2022-04-06
• Last updated: 2023-04-13

Locations

3 sites across 1 country: Indonesia