Immunogenicity and safety of tetravalent dengue vaccines: a systematic review of clinical trials

Tetravalent dengue vaccines have been the subject of study, particularly in the prevention of severe cases of the disease. However, the variability in results and the methodological quality of existing studies raise questions about their effectiveness. The objective is to evaluate the immunogenicity and safety of tetravalent vaccines compared to placebo in the prevention of severe dengue cases through a systematic review of randomized clinical trials. A systematic search was conducted in databases PubMed, Scopus, and Web of Science, including randomized clinical trials published between 2019 and 2024. Inclusion and exclusion criteria were applied to select relevant studies, and methodological quality was assessed using the level of evidence from the Oxford Centre for Evidence-Based Medicine (OCEBM). Six randomized clinical trials were included, with a total of 24,249 participants. The studies evaluated outcomes such as the incidence of severe dengue, seropositivity, and immune response to the vaccines TV003 and TV005. Tetravalent vaccines show a promising outlook in reducing the incidence of severe dengue, although limitations were identified in study designs and heterogeneity in the studied populations. Further research is needed to confirm efficacy and safety in diverse populations.