COVID-19, SARS CoV 2 Infection Clinical Trial
Official title:
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
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.
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. ;