Wagner G, Lavanchy D, Darioli R, Pécoud A, Brulein V, Safary A, Frei P C
Division of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Vaccine. 1993;11(10):1027-32. doi: 10.1016/0264-410x(93)90128-k.
Three hundred travellers, seronegative for hepatitis A, were enrolled into this study to evaluate a new inactivated hepatitis A vaccine. Three injections, each containing at least 720 ELISA units, were administered intramuscularly at months 0, 1 and 6. The subjects were distributed into three groups: 100 received vaccine only; 100 received a single injection of immunoglobulin enriched in HAV antibody; and the 100 remaining travellers received the vaccine and immunoglobulin administered simultaneously with the first vaccine dose. In both vaccinated groups, the rate of seroconversion was found to be higher than 90% at month 1, reaching 100% and 97.8% at month 2 in groups 1 and 3, respectively, and 100% at month 7. In the group receiving both vaccine and immunoglobulin, antibody production was somewhat slower and the final titres were, on average, slightly lower than those obtained in the group with the vaccine alone (GMT 2488 and 3614 mIU ml-1 respectively; p = 0.02). The vaccine appeared to be highly immunogenic in all subjects and was also well tolerated. The slight inhibition of antibody production, induced by the concurrent administration of immunoglobulin, does not affect the overall protection afforded by the vaccine. We conclude that simultaneous active and passive hepatitis A immunizations can be recommended.
300名甲型肝炎血清学阴性的旅行者被纳入本研究，以评估一种新型甲型肝炎灭活疫苗。在第0、1和6个月分别进行三次肌肉注射，每次注射至少含720个ELISA单位。受试者被分为三组：100名仅接种疫苗；100名单次注射富含甲型肝炎病毒（HAV）抗体的免疫球蛋白；其余100名旅行者在接种第一剂疫苗的同时接种疫苗和免疫球蛋白。在两个接种疫苗的组中，第1个月时血清转化率均高于90%，第2个月时第1组和第3组分别达到100%和97.8%，第7个月时均达到100%。在同时接种疫苗和免疫球蛋白的组中，抗体产生稍慢，最终滴度平均略低于仅接种疫苗组（GMT分别为2488和3614 mIU/ml；p = 0.02）。该疫苗在所有受试者中似乎都具有高度免疫原性，且耐受性良好。同时给予免疫球蛋白对抗体产生的轻微抑制并不影响疫苗提供的总体保护。我们得出结论，甲型肝炎主动免疫和被动免疫同时进行是可以推荐的。
