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  • Novel Single-Dose...

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

Written By : Dr Riya Dave |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-02-02T11:15:58+05:30  |  Updated On 12 Feb 2024 11:11 PM IST
Novel Single-Dose Dengue Vaccine Shows High Efficacy in Phase 3 Trial
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In a breakthrough development, the Butantan-Dengue Vaccine (Butantan-DV), an investigational single-dose, live, attenuated, tetravalent vaccine against dengue disease, has demonstrated significant efficacy in an ongoing phase 3 trial in Brazil. The study aims to provide crucial insights into the overall efficacy and safety of Butantan-DV, addressing a critical need for effective dengue prevention strategies. This study was published in The New England Journal Of Medicine by Esper G. and colleagues.

The double-blind trial, spanning a 3-year enrollment period, included 16,235 participants randomly assigned to receive Butantan-DV or a placebo. Stratification was based on age groups (2 to 6 years, 7 to 17 years, and 18 to 59 years), with a planned 5-year follow-up. The primary efficacy endpoint was the prevention of symptomatic, virologically confirmed dengue of any serotype occurring more than 28 days after vaccination. The trial also aimed to assess safety, with primary safety endpoints evaluated up to day 21 post-injection.

  • 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


The New England Journal Of MedicineButantan-DVdengue vaccinetetravalent vaccinephase 3 trialvaccine efficacysafetysingle dosevirologically confirmed denguebreakthroughinfectious diseases
Source : The New England Journal Of Medicine
Dr Riya Dave
Dr Riya Dave

    Dr Riya Dave has completed dentistry from Gujarat University in 2022. She is a dentist and accomplished medical and scientific writer known for her commitment to bridging the gap between clinical expertise and accessible healthcare information. She has been actively involved in writing blogs related to health and wellness.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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