NCT05605470

Immunogenicity and Safety of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 Vaccines as a Booster Dose in Adults

A Phase 2 Study to Evaluate the Immunogenicity and Safety of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 Vaccines as a Booster Dose in Adults Who Have Received a Previous Booster Dose of an Authorized/Approved COVID-19 Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Technovalia, Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is designed to assess the safety, tolerability and immunogenicity of a single dose of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 vaccines as a booster dose, given at least 3 months after receipt of a previous booster dose of any authorized/approved COVID-19 vaccine.

Detailed description

This is a phase II, randomised open-label trial in which 150 healthy males and non-pregnant females aged 18-64 years, will be recruited from multi-sites in Australia. This is a 2-part study (Part A and Part B). In Part A, the randomisation will be a 2:1 design to receive either ChulaCov19 BNA159 vaccine or Comirnaty Pfizer/BNT vaccine. In Part B, participants will receive only ChulaCov19 BNA159.2 (Bivalent, COMVIGEN) vaccine. Participants in part A and B will be followed up using a combination of an-site and telephone visits for assessment of safety and immunogenicity for 6 months post-vaccination.

Conditions

• COVID-19, SARS CoV 2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	ChulaCov19 BNA159 vaccine (50 mcg)	Single dose of ChulaCov19 BNA159 vaccine 0.5 ml will be given by IM at Day 1
BIOLOGICAL	Pfizer/BNT vaccine (30 mcg)	Single dose of Pfizer/BNT vaccine 0.3 ml will be given by IM at Day 1
BIOLOGICAL	COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)	Single dose of COMVIGEN vaccine 0.5 ml will be given by IM at Day 1

Timeline

• Start date: 2023-01-19
• Primary completion: 2024-07-15
• Completion: 2024-11-18
• First posted: 2022-11-04
• Last updated: 2025-04-13

Locations

5 sites across 1 country: Australia