Randomized, double-blind, multicenter study of the immunogenicity and reactogenicity of 17DD and WHO 17D-213/77 yellow fever vaccines in children: Implications for the Brazilian National Immunization Program

被引:14
作者
Bastos Camacho, Luiz Antonio [1 ]
da Silva Freire, Marcos [1 ]
da Luz Fernandes Leal, Maria [1 ]
Souza Maia, Maria De Lourdes [1 ]
Martins, Reinaldo Menezes [1 ]
Yamamoto Yoshida, Anna Maia [1 ]
Sato, Helena Keico [1 ]
Fernandes, Guilherme Cortes [1 ]
Perez de Castro, Ivone [1 ]
Lemos, Jandira Campos [1 ]
Barros, Eugenio Martins [1 ]
Igushi, Takumi [1 ]
Leitdo, Marcia Borges [1 ]
Batista, Maristela [1 ]
da Conceicao Barros, Maria [1 ]
Sao Paulo, Elisabete Paganini [1 ]
Nascimento, Marileide [1 ]
da Silva, Nilce [1 ]
Baran, Meri [1 ]
Pernambuco, Eduardo [1 ]
Leal Costa, Antonio Jose [1 ]
机构
[1] Escola Nacl Saude Publica, BR-21041210 Rio De Janeiro, Brazil
关键词
yellow fever vaccine; clinical trials; randomized controlled trials;
D O I
10.1016/j.vaccine.2007.01.053
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 [免疫学];
摘要
Vaccines against yellow fever currently recommended by the World Health Organization contain either virus sub-strains 17D or 17DD. In adults, the 17DD vaccine demonstrated high seroconversion and similar performance to vaccines manufactured with the WHO 17D-213/77 seed-lot. In another study, 17DD vaccine showed lower seroconversion rates in children younger than 2 years. Data also suggested lower seroconversion with simultaneous application of measles vaccine. This finding in very young children is not consistent with data from studies with 17D vaccines. A multicenter, randomized, double-blind clinical trial was designed (1) to compare the immumogenicity and reactogenicity of two yellow fever vaccines: 17DD (licensed product) and 17D-213/77 (investigational product) in children aged 9-23 months; (2) to assess the effect of simultaneous administration of yellow fever and the measles-mumps-rubella vaccines; and (3) to investigate the interference of maternal antibodies in the response to yellow fever vaccination. The anticipated implications of the results are changes in vaccine sub-strains used in manufacturing YF vaccine used in several countries and changes in the yellow fever vaccination schedule recommendations in national immunization programs. (c) 2007 Elsevier Ltd. All rights reserved.
引用
收藏
页码:3118 / 3123
页数:6
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