IMMUNOGENICITY AND SAFETY OF A NEW INACTIVATED HEPATITIS-A VACCINE IN A COMPARATIVE-STUDY

被引：28

作者：

GOILAV, C

ZUCKERMAN, J

LAFRENZ, M

VIDOR, E

LAUWERS, S

RATHEAU, C

BENICHOU, G

ZUCKERMAN, A

机构：

[1] ROYAL FREE HOSP,SCH MED,OCCUPAT HLTH UNIT,LONDON NW3 2QG,ENGLAND

[2] ROYAL FREE HOSP,SCH MED,WHO,COLLABORATING CTR REFERENCE & RES VIRAL DIS,LONDON NW3 2QG,ENGLAND

[3] UNIV ROSTOCK,INNERE MED KLIN & POLIKLIN,O-2500 ROSTOCK,GERMANY

[4] CTR HOSP A MIGNOT,SERV MED PREVENT,LE CHESNAY,FRANCE

[5] PASTEUR MERIEUX SERUMS & VACCINS,MARNES COQUETTE,FRANCE

[6] CTR HOSP INTERCOMMUNAL,SERV MED PREVENT,POISSY,FRANCE

来源：

JOURNAL OF MEDICAL VIROLOGY | 1995年 / 46卷 / 03期

关键词：

VACCINE TRIAL; HEPATITIS A VACCINE; MULTICENTER STUDY;

D O I：

10.1002/jmv.1890460321

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

A multicentre, controlled, randomised, open, comparative trial including 839 healthy adult volunteers was carried out in order to compare the immunogenicity and reactogenicity of two vaccines against hepatitis A virus (HAV) during primary immunization and after booster injection. The first vaccine was produced by Pasteur Merieux (PM), and the second vaccine by Smith-Kline Beecham (SKB). The vaccination schedule consisted of 2 doses (months 0, 6) for PM and 3 doses (months 0, 1, and 6) for SKB. Two weeks after the first dose, the seroconversion rates among initially HAV seronegative subjects (n = 608) were 93.4% and 76.1% for the PM and SKB vaccines, respectively, the corresponding geometric mean titres (GMTs) were 59.0 mlU/ml versus 30.8 mlU/ml (modified RIA HAVAB assay, Abbott Laboratories). Two months after the beginning of immunization (one dose versus two doses) the GMTs were 138.4 and 161.6 mlU/ml, respectively. At month 7, the seroconversion rates were 100% for both vaccines, and the GMTs were 4,189 and 3,163 mlU/ml, respectively. After the first dose of vaccine, 24.6% and 19.6% of the PM and SKB vaccinees reported local reactions. The rates for systemic reactions were 27.2% and 25.0%, respectively. Lower rates for local and systemic reactions were seen after booster injections and statistical differences were not observed between the two vaccines. The study also demonstrated that vaccination was as well tolerated in subjects with anti-HAV antibodies as in HAV seronegative subjects. Logistic regression analysis revealed a significant vaccine effect on seroconversion rates only at week 2 (P < 10(-4)). The same conclusions were drawn from the analysis of GMT by multivariate regression. When both times (week 2 and week 8) were analysed together, a statistically significant effect of interaction between time and vaccine was observed, indicating that the kinetics of antibody responses were different. (C) 1995 Wiley-Liss, Inc.

引用

页码：287 / 292

页数：6

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