A recombinant live attenuated tetravalent vaccine for the prevention of dengue

被引:47
|
作者
Guy, Bruno [1 ]
Noriega, Fernando [2 ]
Ochiai, R. Leon [3 ]
L'azou, Maina [3 ]
Delore, Valentine [4 ]
Skipetrova, Anna [5 ]
Verdier, Francois [6 ]
Coudeville, Laurent [7 ]
Savarino, Stephen [2 ]
Jackson, Nicholas [1 ]
机构
[1] Sanofi Pasteur, Res & Dev, 2 Ave Pont Pasteur, F-69007 Lyon, France
[2] Sanofi Pasteur, Res & Dev, Swiftwater, PA USA
[3] Sanofi Pasteur, Global Epidemiol, Lyon, France
[4] Sanofi Pasteur, Global Med Affairs, Lyon, France
[5] Sanofi Pasteur, Global Pharmacovigilance, Lyon, France
[6] Sanofi Pasteur, Regulatory Affairs, Marcy Letoile, France
[7] Sanofi Pasteur, Vaccinat Value Modeling, Lyon, France
关键词
Dengue; vaccine; human; efficacy; safety; immunology; FLAVIVIRUS-NAIVE ADULTS; PHASE-II; HEALTHY-ADULTS; SAFETY; IMMUNOGENICITY; CHILDREN; ADOLESCENTS; TRIAL; PROTECTION; FORMULATIONS;
D O I
10.1080/14760584.2017.1335201
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Introduction: Dengue is an important and still growing public health problem associated with substantial morbidity, as well as significant social and economic impact. The present review describes the main features and development of the first dengue vaccine (CYD-TDV, Dengvaxia (R)), which has been licensed by several dengue-endemic countries in Asia and Latin America for use in populations above 9years of age.Areas covered: The review focuses on the large clinical development of CYD-TDV, which includes in particular two pivotal phase III efficacy trials conducted in Asia and Latin America and supported vaccine licensure. Based on these clinical data, the WHO Strategic Advisory Group of Experts (SAGE) on Immunization recommended considering introduction of the vaccine in geographic settings (national or subnational) with high burden of disease. Long-term safety follow-up studies of the efficacy trials are currently ongoing, and post-licensure studies will evaluate the vaccine effectiveness and safety in real-life' following vaccine introduction.Expert commentary: During vaccine development, a number of complexities were tackled, innovation pursued, and risk managed. These aspects, as well as the potential impact of CYD-TDV on public health are also discussed.
引用
收藏
页码:671 / 683
页数:13
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