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新型17D耐热黄热病疫苗的比较临床研究

Comparative clinical study of a new 17D thermostable yellow fever vaccine.

作者信息

Roche J C, Jouan A, Brisou B, Rodhain R, Fritzell B, Hannoun C

出版信息

Vaccine. 1986 Sep;4(3):163-5. doi: 10.1016/0264-410x(86)90004-6.

Abstract

The immunogenicity and the safety of a new heat-stable 17D yellow fever vaccine have been assessed in a randomized comparative study by reference to a non-stabilized vaccine preparation. Seronegative adults were used and 115 and 143 were given the heat-stable and the non-stabilized vaccine, respectively. Fifty two days after the immunization, haemagglutination inhibiting antibodies were found in 77.6 and 73.9% of the vaccinees, neutralizing antibodies in 99.3 and 100% of them. The percentage of seroconversion and the geometric mean of antibody titres were not significantly different. No complaints or adverse reactions in association with the vaccines were recorded. This study demonstrates the high immunogenicity of this new stabilized vaccine whose stability has already been proven.

摘要

通过参照一种非稳定化疫苗制剂,在一项随机对照研究中评估了一种新型热稳定17D黄热病疫苗的免疫原性和安全性。使用血清阴性的成年人,分别有115人和143人接种了热稳定疫苗和非稳定化疫苗。免疫接种52天后,分别有77.6%和73.9%的接种者出现血凝抑制抗体,99.3%和100%的接种者出现中和抗体。血清转化率和抗体滴度几何平均值差异无统计学意义。未记录到与疫苗相关的主诉或不良反应。这项研究证明了这种新型稳定化疫苗具有高免疫原性,其稳定性已得到证实。

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