Vacuna monodosis | 15 ABR 24

Vacuna de Dengue Butantan para niños y adultos

Ensayo en curso fase 3, doble ciego, randomizado sobre seguridad y eficacia de la vacuna viva, atenuada, tetravalente Butantan en niños y adultos
Autor/a: E.G. Kallás, M.A.T. Cintra, J.A. Moreira, E.G. Patiño, P.E. Braga, J.C.V. Tenório, et al. Fuente: N Engl J Med 2024; 390:397-408. DOI: 10.1056/NEJMoa2301790  Live, Attenuated, Tetravalent ButantanDengue Vaccine in Children and Adults
INDICE:  1. Página 1 | 2. Referencias bibliográficas
Referencias bibliográficas

Referencias    

1. Bhatt S, Gething PW, Brady OJ, et al. The global distribution and burden of dengue. Nature 2013;496:504-7.

2. Dengue: guidelines for diagnosis, treatment, prevention and control. Geneva: World Health Organization, 2009.

3. Simmons CP, Farrar JJ, van Vinh Chau N, Wills B. Dengue. N Engl J Med 2012; 366:1423-32.

4. Stanaway JD, Shepard DS, Undurraga EA, et al. The global burden of dengue: an analysis from the Global Burden of Disease Study 2013. Lancet Infect Dis 2016; 16:712-23.

5. Junior JBS, Massad E, Lobao-Neto A, Kastner R, Oliver L, Gallagher E. Epidemiology and costs of dengue in Brazil: a systematic literature review. Int J Infect Dis 2022;122:521-8.

6. Halstead SB. Pathogenesis of dengue: challenges to molecular biology. Science 1988;239:476-81.

7. Katzelnick LC, Gresh L, Halloran ME, et al. Antibody-dependent enhancement of severe dengue disease in humans. Science 2017;358:929-32.

8. Capeding MR, Tran NH, Hadinegoro SR, et al. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial. Lancet 2014;384:1358-65.

9. Villar L, Dayan GH, Arredondo-García JL, et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med 2015;372:113-23.

10. Sridhar S, Luedtke A, Langevin E, et al. Effect of dengue serostatus on dengue vaccine safety and efficacy. N Engl J Med 2018;379:327-40.

11. Hadinegoro SR, Arredondo-García JL, Capeding MR, et al. Efficacy and longterm safety of a dengue vaccine in regions of endemic disease. N Engl J Med 2015; 373:1195-206.

12. Dengue vaccine: WHO position paper, September 2018 — recommendations. Vaccine 2019;37:4848-9.

13. Biswal S, Reynales H, Saez-Llorens X, et al. Efficacy of a tetravalent dengue vaccine in healthy children and adolescents. N Engl J Med 2019;381:2009-19.

14. Takeda. Takeda’s Qdenga (dengue tetravalent vaccine [live, attenuated]) approved in Indonesia for use regardless of prior dengue exposure. August 22, 2022 (https:// www.takeda.com/newsroom/newsreleases/ 2022/takedas-qdenga-dengue-tetravalent -vaccine-live-attenuated-approved-in -indonesia-for-use-regardless-of-prior -dengue-exposure).

15. Takeda. Takeda’s Qdenga (dengue tetravalent vaccine [live, attenuated]) approved for use in European Union. December 8, 2022 (https://www.takeda.com/newsroom/ newsreleases/2022/takedas-qdenga-dengue -tetravalent-vaccine-live-attenuated-approved -for-use-in-european-union).

16. Agência Nacional de Vigilância Sanitária (Anvisa). Anvisa aprova nova vacina contra a dengue. March 2, 2023 (https:// www.gov.br/anvisa/pt-br/assuntos/noticias -anvisa/2023/anvisa-aprova-nova-vacina -para-a-dengue).

17. Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol 2006;19: 10-32.

18. Durbin AP, Kirkpatrick BD, Pierce KK, et al. A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-naive adults: a randomized, doubleblind clinical trial. J Infect Dis 2013;207: 957-65.

19. Durbin AP, Kirkpatrick BD, Pierce KK, et al. A 12-month-interval dosing study in adults indicates that a single dose of the national institute of allergy and infectious diseases tetravalent dengue vaccine induces a robust neutralizing antibody response. J Infect Dis 2016;214:832-5.

20. Kirkpatrick BD, Durbin AP, Pierce KK, et al. Robust and balanced immune responses to all 4 dengue virus serotypes following administration of a single dose of a live attenuated tetravalent dengue vaccine to healthy, flavivirus-naive adults. J Infect Dis 2015;212:702-10.

21. Russell KL, Rupp RE, Morales-Ramirez JO, et al. A phase I randomized, doubleblind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a live-attenuated quadrivalent dengue vaccine in flavivirus-naïve and flavivirus experienced healthy adults. Hum Vaccin Immunother 2022;18:2046960

 

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