Phase 3 clinical trial shows favorable safety and immunogenicity profile of single-shot live-attenuated chikungunya vaccine TheLancet cinicaltrail vaccine research news immunology immunogenicity
By Neha MathurJun 15 2023Reviewed by Lily Ramsey, LLM In this review published in The Lancet, researchers performed a double-blinded, phase III randomized trial to gather safety and immunogenicity data for a live-attenuated vaccine candidate 'VLA1553' for the chikungunya virus. They reported data up to day 180 post-vaccination for 4,115 healthy participants.
Based on its phase I clinical trial findings, the researchers found that VLA1553 had a good safety profile and high immunogenicity. More importantly, they identified that its medium dose of 1 × 104 per 0·5 mL of 50% Tissue Culture Infectious Dose was ideal for further development. The primary endpoint of the trial was to assess the proportion of participants with a seroprotective chikungunya virus antibody level at baseline, defined as a 50% plaque reduction in micro plaque reduction neutralization test of ≥150 for negative baseline participants, 28 days post-vaccination.
In fact, a Data Safety Monitoring Board regularly reviewed accumulating safety information till day 180, i.e., the end-of-study. The authors noted that VLA1553-induced neutralizing antibody titers against the chikungunya virus were protective and well-tolerable for nearly all participants, regardless of age, i.e., in younger and older adults.
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