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Vaccine. 2017 Jun 14;35(27):3452-3456. doi: 10.1016/j.vaccine.2017.05.003. Epub 2017 May 18.

Dengue vaccine safety signal: Immune enhancement, waning immunity, or chance occurrence?

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Agence de Médecine Preventive (AMP), Paris, France. Electronic address:
Institute for Vaccine Safety, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.


A new dengue vaccine was associated with increased risk of hospitalized virologically-confirmed disease during year 3 of follow-up among children age 2-5years. Among hypotheses to explain this finding, we could not distinguish definitively between antibody dependent enhancement, waning immunity, or chance occurrence. However, any theory must account for the following: (a) the signal occurred mainly because of decreased dengue among controls rather than increased dengue among vaccinees; (b) among 48 data points, a statistically significant increase in hospitalization among vaccinated children occurred for only one age group, during one year, and in one region; (c) cumulative risk was similar for vaccinated vs. control children age 2-5years at the end of year 5 and lower for vaccinated vs. control children among older age groups; (d) the protective effect of vaccine against hospitalization decreased from years 1-2 to years 3-5 of follow-up for all age groups and regions.


Adverse events following immunization; Clinical trial; Dengue; Immunization; Safety; Vaccine

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