Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial

Capeding, María Rosario; Tran, Ngoc Huu; Hadinegoro, Sri Rezeki; Ismail, Hussain Imam Hj Muhammad; Chotpitayasunondh, Tawee; Chua, Mary Noreen; Luong, Chan Quang; Rusmil, Kusnandi; Wirawan, Dewa Nyoman; Nallusamy, Revathy; Pitisuttithum, Punnee; Thisyakorn, Usa; Yoon, In Kyu; Vliet, Diane van der; Langevin, Edith; Laot, Thelma; Hutagalung, Yanee; Frago, Carina; Boaz, Mark; Wartel, T. Anh; Tornieporth, Nadia; Saville, Mélanie; Bouckenooghe, Alain

doi:10.1016/s0140-6736(14)61060-6

Cited by 859 publications

(882 citation statements)

References 14 publications

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“…seronegativeAve. FOIIndonesia1870430.2190.2Malaysia1401322.35113.1Philippines3501805.18145.2Thailand2666613.30184.15Thailand1170269.2259.15Vietnam2333537.35188.18Brazil2370782.34266.1Colombia64972144.10214.22Honduras1866616.1592.18Mexico2312763.44336.08Puerto Rico875289.46133.15Totals 7570 18201.71/11 = 0.155aCapeding et al, Thailand component 12 bSabchareon et al 11 …”

Section: Resultsmentioning

confidence: 99%

Safety issues from a Phase 3 clinical trial of a live-attenuated chimeric yellow fever tetravalent dengue vaccine

Halstead

2018

Human Vaccines & Immunotherapeutics

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A tetravalent live-attenuated 3-dose vaccine composed of chimeras of yellow fever 17D and the four dengue viruses (CYD, also called Dengvaxia) completed phase 3 clinical testing in over 35,000 children leading to a recommendation that vaccine be administered to >/ = 9 year-olds residing in highly dengue- endemic countries. When clinical trial results were assessed 2 years after the first dose, vaccine efficacy among seropositives was high, but among seronegatives efficacy was marginal. Breakthrough dengue hospitalizations of vaccinated children occurred continuously over a period of 4–5 years post 3rd dose in an age distribution suggesting these children had been vaccinated when seronegative. This surmise was validated recently when the manufacturer reported that dengue NS1 IgG antibodies were absent in sera from hospitalized vaccinated children, an observation consistent with their having received Dengvaxia when seronegative. Based upon published efficacy data and in compliance with initial published recommendations by the manufacturer and WHO the Philippine government undertook to vaccinate 800,000-plus 9 year-olds starting in April 2016. Eighteen months later, dengue hospitalizations and a deaths were reported among vaccinated children. The benefits of administering Dengvaxia predicted by the manufacturer, WHO and others derive from scoring dengue hospitalizations of vaccinated children as vaccine failures rather than as vaccine enhanced dengue disease. Recommended regimens for administration of Dengvaxia should have been structured to warn of and avoid serious adverse events.

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Section: Resultsmentioning

confidence: 99%

Safety issues from a Phase 3 clinical trial of a live-attenuated chimeric yellow fever tetravalent dengue vaccine

Halstead

2018

Human Vaccines & Immunotherapeutics

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“…Dengue outbreaks are typically highly visible in the international media, and tourists may decide to avoid travel to countries experiencing an outbreak (58,59,73,74). Although a dengue vaccine is not yet available, promising candidates are under development (75). Studies are needed of the causal effect of dengue outbreaks on tourism streams and revenues to test the claim that dengue vaccination can generate positive community economic externalities by reducing the frequency and intensity of outbreaks.…”

Section: Discussionmentioning

confidence: 99%

Valuing vaccination

Bärnighausen

Bloom

Cafiero-Fonseca

et al. 2014

Proc. Natl. Acad. Sci. U.S.A.

166

149

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Vaccination has led to remarkable health gains over the last century. However, large coverage gaps remain, which will require significant financial resources and political will to address. In recent years, a compelling line of inquiry has established the economic benefits of health, at both the individual and aggregate levels. Most existing economic evaluations of particular health interventions fail to account for this new research, leading to potentially sizable undervaluation of those interventions. In line with this new research, we set forth a framework for conceptualizing the full benefits of vaccination, including avoided medical care costs, outcome-related productivity gains, behavior-related productivity gains, community health externalities, community economic externalities, and the value of risk reduction and pure health gains. We also review literature highlighting the magnitude of these sources of benefit for different vaccinations. Finally, we outline the steps that need to be taken to implement a broad-approach economic evaluation and discuss the implications of this work for research, policy, and resource allocation for vaccine development and delivery.benefit-cost analysis | immunization

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“…The DENV proteins prM and E for each of the four serotypes were inserted into the backbone of the YFV 17D vaccine strain. Two large phase III clinical trials have been completed in over 30,000 children resulting in an overall vaccine efficacy of66% [48,49]. However, the serotype-specific efficacy for DENV2 was poor with less than 43%.…”

Section: Dengue Virusmentioning

confidence: 99%