Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study

Sci Rep. 2024 Jan 29;14(1):2373. doi: 10.1038/s41598-023-49653-6.

Abstract

ChulaCov19 mRNA vaccine demonstrated promising phase 1 results. Healthy adults aged 18-59 years were double-blind randomised 4:1 to receive two intramuscular doses of ChulaCov19 50 µg or placebo. Primary endpoints were safety and microneutralization antibody against-wild-type (Micro-VNT50) at day 50. One hundred fifty adults with median (IQR) age 37 (30-46) years were randomised. ChulaCov19 was well tolerated, and most adverse events were mild to moderate and temporary. Geometric mean titres (GMT) of neutralizing titre against wild-type for ChulaCov19 on day 50 were 1367 IU/mL. T-cell IFN-γ-ELISpot showed the highest responses at one week (Day29) after dose 2 then gradually declined. ChulaCov19 50 µg is well tolerated and elicited high neutralizing antibodies and strong T-cell responses in healthy adults.Trial registration number: ClinicalTrials.gov Identifier NCT04566276, 28/09/2020.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Neutralizing
  • Antibodies, Viral
  • COVID-19 Vaccines* / adverse effects
  • COVID-19* / prevention & control
  • Double-Blind Method
  • Humans
  • Immunogenicity, Vaccine
  • Middle Aged
  • Young Adult
  • mRNA Vaccines

Substances

  • Antibodies, Neutralizing
  • Antibodies, Viral
  • ChulaCov19 vaccine
  • COVID-19 Vaccines
  • mRNA Vaccines

Associated data

  • ClinicalTrials.gov/NCT04566276