Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial

@article{Biswal2020EfficacyOA,
  title={Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial},
  author={Shibadas Biswal and Charissa Fay Corazon Borja-Tabora and Luis Martinez Vargas and Hector Vel{\'a}squez and Maria Theresa P. Alera and Victor Y. Sierra and Edith Johana Rodriguez-Arenales and Delia Yu and Vithanage Pujitha Wickramasinghe and Edson Duarte Moreira and Asvini D. Fernando and Dulanie Gunasekera and Pope Kosalaraksa and F{\'e}lix Espinoza and Eduardo L{\'o}pez-Medina and Lulu C. Bravo and Suely Hiromi Tuboi and Yanee Hutagalung and Pedro Garbes and Ian Escudero and Martina Rauscher and Svetlana Bizjajeva and Inge Lefevre and Astrid Borkowski and Xavier S{\'a}ez-Llorens and Derek Wallace and Alys Concepci{\'o}n and Ana Cecilia Villarreal and Asvini D. Fernando and Chukiat Sirivichayakul and Edith Johana Rodriguez-Arenales and Humberto Reynales and Kleber Giovanni Luz and Jose ¤ Jimeno and Lakkumar Fernando and Luis Rivera and Onanong Manacharoen and P{\'i}o L{\'o}pez and Vithanage Pujitha Wickramasinghe and Reynaldo Dietze and Rivaldo Ven{\^a}ncio da Cunha and Veerachai Watanaveeradej and Manja Brose and Kelley J Moss and Seetha Meyer and Vianney Tricou},
  journal={The Lancet},
  year={2020},
  volume={395},
  pages={1423-1433}
}
BACKGROUND A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years. METHODS We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and… Expand
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Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17 years: a randomised, placebo-controlled, phase 2 trial
TLDR
Results from this study provide a long-term safety database and support assessment of the vaccine in the ongoing phase 3 efficacy study of TAK-003. Expand
Long-term safety and immunogenicity of a tetravalent dengue vaccine candidate in children and adults: a randomized, placebo-controlled, phase 2 study.
TLDR
The trial demonstrated persistence of neutralizing antibody titers against TAK-003 over three years in children and adults living in dengue endemic countries, with limited contribution from natural infection. Expand
Efficacy of a dengue vaccine candidate (TAK-003) in healthy children and adolescents two years after vaccination.
TLDR
TAK-003 demonstrated continued benefit independent of baseline serostatus in reducing dengue with some decline in efficacy during the second year, and three-year data will be important to see if efficacy stabilizes or declines further. Expand
Immunogenicity and safety of a tetravalent dengue vaccine in dengue-naïve adolescents in Mexico City
TLDR
TAK-003 was immunogenic against all four serotypes and was well tolerated in dengue-naïve adolescents living in Mexico City, an area considered non-endemic for d Dengue. Expand
Defining levels of dengue virus serotype-specific neutralizing antibodies induced by a live attenuated tetravalent dengue vaccine (TAK-003)
TLDR
The results indicate that the presence of neutralizing antibodies alone are not a reliable indicator of the immunogenicity of each vaccine component, and concludes that the DENV2 component in the vaccine is immunodominant because of the high levels of serumneutralizing antibodies targeting type-specific epitopes. Expand
Defining levels of dengue virus serotype-specific neutralizing antibodies induced by a live attenuated tetravalent dengue vaccine (TAK-003)
TLDR
It is demonstrated that TAK-003 induced high levels ofDENV2 neutralizing antibodies that recognized unique (type-specific) epitopes on DENV2, and most vaccinated subjects developed lower levels of DENV1, DENV3 and DENV4 neutralizing antibody that mainly targeted epitopes that were conserved (cross-reactive) between serotypes. Expand
Dengue Virus and Vaccines: How Can DNA Immunization Contribute to This Challenge?
Dengue infections still have a tremendous impact on public health systems in most countries in tropical and subtropical regions. The disease is systemic and dynamic with broad range of… Expand
The Impact of Serotype Cross-Protection on Vaccine Trials: DENVax as a Case Study
There is a growing public health need for effective preventive interventions against dengue, and a safe, effective and affordable dengue vaccine against the four serotypes would be a significant… Expand
The Impact of Serotype Cross-Protection on Vaccine Trials: DENVax as a Case Study
TLDR
It is noted, after comparing the VE estimations for 12- and 18-month periods, that vaccine efficacy is decreasing over time, and the discussion of the role of temporary cross-immunity in dengue vaccine trials and the impact of serostatus prior to vaccination is brought up. Expand
An update on dengue vaccine development, challenges, and future perspectives
TLDR
The authors propose to explore various adjuvants and delivery systems that may help improve the design of safe, effective, and affordable vaccines against dengue as increasing evidence support that DENV strains have evolved different virulence mechanisms. Expand
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References

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Results from this study provide a long-term safety database and support assessment of the vaccine in the ongoing phase 3 efficacy study of TAK-003. Expand
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