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2016, Number 1

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Rev Cubana Invest Bioméd 2016; 35 (1)

Safety and immunogenicity in clinical trials of dengue vaccines

Reyes CJC, Cardona-Arias JA, López JÁ, Martinez-Gutierrez M

Language: Spanish
References: 72
Page: 78-90
PDF size: 431.02 Kb.


ABSTRACT

Introduction: One of the obstacles for the licensing of a dengue vaccine is the variability of studies, which hampers their joint analysis to reach reliable conclusions.
Objectives: Perform a systematic literature review aimed at analyzing the safety and immunogenicity of the various dengue vaccines.
Methods: Information was searched for in Cochrane Library, Scopus, Science Direct, PubMed, Nature, Lilacs and OvidSp, based on pearl harvest methodology in keeping with the inclusion criteria.
Results: Forty-two papers were selected. The main symptoms reported in the studies included erythema, pain and tenderness. Great discrepancy was found in the definition of seropositivity, as well as great variability in the geometric mean titers reported by each study.
Conclusions: Studies showed great variability concerning the design and report of safety and immunogenicity data.


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