NCT05933278

Homologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

Immunogenicity & Safety of IndoVac® as a Homologous Booster Dose Against COVID-19 in Adults Aged 18 Years and Above in Indonesia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Open-label, prospective intervention study of IndoVac® as a single, homologous booster dose

Detailed description

This trial is open-label, prospective intervention study. A total of 150 subjects who had previously received complete primary doses of IndoVac® in phase III and are willing to participate in the study by signing the consent form, will be involved in this trial. The regimen of the vaccine 0.5 ml injected as a single booster dose. Evaluation will be conducted for safety and immunogenicity for all subjects. Safety evaluation include AEs until 28 days post booster dose, with AESIs and SAEs throughout the trial. Immunogenicity evaluation will compare pre-booster antibody titer (baseline) to post- booster antibody titer at 14 days, 28 days, 3 months, 6 months, and 12 months timepoint. Interim evaluation will be performed at 14 days post booster dose for Emergency Use Authorization (EUA) consideration. All subjects will be followed up until 12 months post booster dose.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Subunit Recombinant Protein Vaccine	SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT Bio Farma

Timeline

• Start date: 2023-07-25
• Primary completion: 2024-08-31
• Completion: 2024-09-05
• First posted: 2023-07-06
• Last updated: 2025-06-05

Locations

1 site across 1 country: Indonesia