Caveat and limitations
infection, dengue
INFECTION, CNS INFECTIONS, DENGUE
With regard to limitations of the study, the small sample size precludes any statistical analysis of the safety data and may have limited the statistical significance of any changes in immunogenicity measures. Regarding immunogenicity analysis, one limitation is the use of RDT to exclude prior DENV infection at screening, since its sensitivity for past infections in non-endemic settings has been shown to be low.Overall, results of this clinical trial of a synthetic nanoparticle-based, T cell priming peptide vaccine against a viral pathogen were positive. Although local mild reactions were frequent, the vaccine appeared to be safe with no vaccine-related SAEs reported. Furthermore, results indicate proof of concept that specific peptides attached to a nanoparticle carrier as a vaccine can successfully induce virus-specific effector and memory CD8+ T cell responses. These findings are encouraging for further clinical trials, involving larger numbers of subjects, to investigate this innovative dengue vaccine candidate.