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Tetravalent Dengue Vaccine: A Review in the Prevention of Dengue Disease

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Abstract

Tetravalent, live-attenuated, dengue vaccine (Dengvaxia®; CYD-TDV) is the first vaccine approved for the prevention of dengue disease caused by dengue virus (DENV) serotypes 1–4 in individuals aged 9–45 or 9–60 years living in high dengue endemic areas. This narrative review discusses the immunogenicity, protective efficacy, reactogenicity and safety of CYD-TDV in the prevention of dengue disease. In Latin American and Asian phase 3 trials in children and adolescents (n > 30,000), the recommended three-dose CYD-TDV regimen was efficacious in preventing virologically-confirmed dengue (VCD) during the period from 28 days after the last dose (month 13) to month 25, meeting the primary endpoint criteria. Protective efficacy against VCD in the respective individual trials was 60.8 and 56.5 % (primary analysis). During the 25-month active surveillance phase, CYD-TDV also provided protective efficacy against VCD, severe dengue, any grade of dengue haemorrhagic fever and VCD-related hospitalization in children aged 9 years and older. CYD-TDV was generally well tolerated, with no safety concerns identified after up to 4 years’ follow-up (i.e. from post dose 1) in ongoing long-term studies. Based on evidence from the dengue clinical trial program, the WHO SAGE recommended that countries with high dengue endemicity consider introducing CYD-TDV as part of an integrated disease prevention strategy to lower disease burden. Pharmacoeconomic considerations will be pivotal to implementing dengue vaccination prevention strategies in these countries. The availability of a dengue vaccine is considered essential if the 2012 WHO global strategy targets for reducing the burden of dengue disease by 2020 are to be attained. Hence, CYD-TDV represents a major advance for the prevention of dengue disease in high dengue endemic regions.

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Acknowledgments

During the peer review process, the manufacturer of the tetravalent live-attenuated dengue vaccine was offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Lesley J. Scott

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The preparation of this review was not supported by any external funding.

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Lesley Scott is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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The manuscript was reviewed by: H. G. Dantes, Instituto Nacional de Salud Publica, Cuernavaca, Morelos, Mexico; M.-T. Koh, Department of Paediatrics, Faculty of Medicine University of Malaya, Clinical Investigation Centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia; P. W. Orellano, Universidad Tecnologica Nacional, CONICET, Facultad Regional San Nicolas, San Nicolas, Argentina; J. Torresi, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.

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Scott, L.J. Tetravalent Dengue Vaccine: A Review in the Prevention of Dengue Disease. Drugs 76, 1301–1312 (2016). https://doi.org/10.1007/s40265-016-0626-8

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