Long-term efficacy and safety of the single-dose tetravalent Butantan dengue vaccine - PubMed
12 hours ago
- #dengue vaccine
- #public health
- #clinical trial
- The Butantan dengue vaccine (Butantan-DV) is a single-dose, live, attenuated, tetravalent vaccine designed to protect against all four dengue virus (DENV) serotypes.
- A phase 3 trial in Brazil involving 16,235 participants (ages 2-59) demonstrated the vaccine's efficacy and safety over a 5-year follow-up period.
- Overall vaccine efficacy (VE) was 65.0% (95% CI: 57.8-71.0%) against symptomatic dengue caused by any DENV serotype, regardless of prior dengue exposure.
- VE was higher in dengue-experienced participants (77.1%) compared to dengue-naive participants (58.9%).
- The vaccine showed efficacy against DENV-1 (73.0%) and DENV-2 (55.7%), with no observed cases of DENV-3 or DENV-4.
- VE against severe dengue or dengue with warning signs was 80.5%.
- Common solicited adverse events included headache (36.7% in vaccine recipients vs. 31.1% in placebo recipients), mostly mild (grade 1).
- No significant safety concerns were identified during the 5-year follow-up.
- The trial met its primary and secondary objectives, confirming the vaccine's efficacy and safety profile.