灭活病毒体与明矾吸附甲型肝炎疫苗的免疫原性及不良反应：一项随机对照试验

Immunogenicity and adverse effects of inactivated virosome versus alum-adsorbed hepatitis A vaccine: a randomized controlled trial.

作者信息

Holzer B R, Hatz C, Schmidt-Sissolak D, Glück R, Althaus B, Egger M

机构信息

University Medical Policlinic, University of Berne, Switzerland.

出版信息

Vaccine. 1996 Jul;14(10):982-6. doi: 10.1016/0264-410x(96)00042-4.

DOI:10.1016/0264-410x(96)00042-4

PMID:8873392

Abstract

Immunogenicity and adverse effects of a novel inactivated hepatitis A vaccine based on virosomes (IRIV-HAV) was compared with a standard vaccine adsorbed to aluminium (Al-HAV). Seronegative volunteers (n = 301) were randomly allocated to one injection of IRIV-HAV or to two injections of Al-HAV, followed by a booster injection at 12 months. Two hundred and ninety-eight (99%) completed the first month and 215 (71%) could be evaluated at 1 year. Geometric mean antibody concentrations at days 0, 14 and at 12 months were similar in the two vaccine groups. Lower antibody concentrations were recorded with IRIV-HAV at day 28 (P < 0.0001) and at 13 months (P = 0.02). Seroconversion to protective antibody levels, however, was similar (98% at day 28, 94% at 12 months, 100% at 13 months). Local adverse effects were reported in 17% with IRIV-HAV but in 66% with Al-HAV (P < 0.0001) after the initial vaccination and in 32% and 42% following the booster vaccination (P = 0.05). In conclusion, IRIV-HAV may provide similar protection but cause less local adverse effects.

摘要

将基于病毒体的新型甲型肝炎灭活疫苗（IRIV-HAV）与吸附于铝的标准疫苗（Al-HAV）的免疫原性和不良反应进行了比较。血清学阴性志愿者（n = 301）被随机分配接受一剂IRIV-HAV或两剂Al-HAV注射，随后在12个月时进行加强注射。298名（99%）完成了第一个月的观察，215名（71%）在1年时可进行评估。两个疫苗组在第0天、第14天和第12个月时的几何平均抗体浓度相似。在第28天（P < 0.0001）和第13个月（P = 0.02）时，IRIV-HAV组的抗体浓度较低。然而，血清转化为保护性抗体水平的情况相似（第28天为98%，第12个月为94%，第13个月为100%）。初次接种疫苗后，IRIV-HAV组有17%报告了局部不良反应，而Al-HAV组为66%（P < 0.0001）；加强接种后，这一比例分别为32%和42%（P = 0.05）。总之，IRIV-HAV可能提供相似的保护作用，但引起的局部不良反应较少。