NCT05228613

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018

Detailed description

This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above). The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 protein subunit recombinant vaccine	candidate vaccine manufactured by PT. Bio Farma
BIOLOGICAL	SARS-CoV-2 inactivated vaccine	active control manufactured by Sinovac Life Sciences Co.Ltd

Timeline

• Start date: 2022-02-16
• Primary completion: 2022-08-02
• Completion: 2023-01-24
• First posted: 2022-02-08
• Last updated: 2023-02-27

Locations

2 sites across 1 country: Indonesia