Novel Single-Dose Dengue Vaccine Shows High Efficacy in Phase 3 Trial

• After 2 years of follow-up, Butantan-DV demonstrated an overall vaccine efficacy of 79.6%.

• Notably, efficacy was 73.6% among participants with no previous dengue exposure and an impressive 89.2% among those with a history of exposure.

• Age-specific efficacy revealed promising results: 80.1% in participants aged 2 to 6 years, 77.8% in those 7 to 17 years, and 90.0% in the 18 to 59 years age group.

• The vaccine showed efficacy against DENV-1 at 89.5%, and DENV-2 at 69.6%, with no detection of DENV-3 and DENV-4 during the follow-up period.

• However, solicited systemic vaccine-related adverse events within 21 days were more common with Butantan-DV compared to the placebo (58.3% vs. 45.6%).

This groundbreaking study reveals that a single dose of Butantan-DV effectively prevents symptomatic DENV-1 and DENV-2, irrespective of participants' dengue serostatus at baseline, over a 2-year follow-up. The vaccine demonstrates high efficacy across various age groups and serotypes, marking a significant advancement in dengue prevention.

Reference:

Kallás, E. G., Cintra, M. A. T., Moreira, J. A., Patiño, E. G., Braga, P. E., Tenório, J. C. V., Infante, V., Palacios, R., de Lacerda, M. V. G., Batista Pereira, D., da Fonseca, A. J., Gurgel, R. Q., Coelho, I. C.-B., Fontes, C. J. F., Marques, E. T. A., Romero, G. A. S., Teixeira, M. M., Siqueira, A. M., Barral, A. M. P., … Nogueira, M. L. Live, attenuated, tetravalent Butantan–dengue vaccine in children and adults. The New England Journal of Medicine,2024;390(5):397–408. https://doi.org/10.1056/nejmoa230179