Safety and immunogenicity of hepatitis A vaccine in patients with chronic liver disease

被引:187
作者
Keeffe, EB
Iwarson, S
McMahon, BJ
Lindsay, KL
Koff, RS
Manns, M
Baumgarten, R
Wiese, M
Fourneau, M
Safary, A
Clemens, R
Krause, DS
机构
[1] Stanford Univ, Med Ctr, Palo Alto, CA 94304 USA
[2] Gothenburg Univ, Gothenburg, Sweden
[3] Ctr Dis Control, Arctic Invest Program, Anchorage, AK USA
[4] Univ So Calif, Los Angeles, CA USA
[5] Columbia MetroWest Med Ctr, Framingham, MA USA
[6] Leibniz Univ Hannover, Hannover, Germany
[7] Staedt Krankenhaus Prenzlauer Berg, Berlin, Germany
[8] Stadt Klinikum St Georg, Leipzig, Germany
[9] SmithKline Beecham Biol, Rixensart, Belgium
[10] SmithKline Beecham Pharmaceut, Collegeville, PA USA
关键词
D O I
10.1002/hep.510270336
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Acute hepatitis A superimposed on chronic liver disease (CLD) has been associated with severe or fulminant hepatitis, An open, multicenter study was performed to compare the safety and immunogenicity of an inactivated hepatitis A vaccine in patients with CLD with that in healthy subjects. A secondary objective was to compare the safety of the hepatitis A vaccine with that of a commercial hepatitis B vaccine in subjects with chronic hepatitis C. A total of 475 subjects over the age of 18 years were enrolled into 1 of 5 groups according to history, serological data, and previous diagnosis, Patients in groups 1 (healthy adults), 2 (chronic hepatitis B), 3 (chronic hepatitis C), and 5 (other CLD not caused by viral hepatitis) were vaccinated with two doses of inactivated hepatitis A vaccine, 6 months apart, Patients in group 4 (chronic hepatitis C) received 3 doses of a recombinant hepatitis B vaccine, according to a 0-, 1-, and 6-month schedule, Local injection-site symptoms were the most common reactions reported following vaccination in all groups (35.5% of all doses), with the hepatitis B vaccine eliciting fewer injection-site symptoms than the hepatitis A vaccine (19.8% compared with 37.5%), Although a higher percentage of healthy subjects (93%) seroconverted after a single dose of the hepatitis A vaccine than did subjects with chronic hepatitis C (73.7%) or CLD of nonviral etiologies (83.1%), more than 94% of all vaccinees were seropositive for anti-HAN after the complete vaccination course. At each time point, a lower geometric mean concentration of anti-HAV was observed for each group of CLD patients compared with the healthy control subjects, In conclusion, hepatitis A vaccine was well tolerated and induced a satisfactory immune response in patients with chronic hepatitis B, chronic hepatitis C, and miscellaneous CLD.
引用
收藏
页码:881 / 886
页数:6
相关论文
共 34 条
[21]   INTERRUPTION OF AN OUTBREAK OF HEPATITIS-A IN 2 VILLAGES BY VACCINATION [J].
PRIKAZSKY, V ;
OLEAR, V ;
CERNOCH, A ;
SAFARY, A ;
ANDRE, FE .
JOURNAL OF MEDICAL VIROLOGY, 1994, 44 (04) :457-459
[22]   PLACEBO-CONTROLLED EFFICACY STUDY OF HEPATITIS-A VACCINE IN VALDIVIA, CHILE [J].
RIEDEMANN, S ;
REINHARDT, G ;
FROSNER, GG ;
IBARRA, H ;
MORALEDA, L ;
HERING, V ;
SIEGEL, F ;
TOLEDO, C ;
LEON, J ;
GONZALEZ, JL ;
DELEM, A ;
SAFARY, A .
VACCINE, 1992, 10 :S152-S155
[23]   VACCINATION AGAINST HEPATITIS-A VIRUS IN FRENCH HOMOPHILIC CHILDREN [J].
ROTHSCHILD, C ;
POL, S ;
MATTLINGER, B ;
REIJASSE, D ;
TORCHET, MF ;
GAZENGEL, C .
VOX SANGUINIS, 1995, 69 (01) :80-81
[24]  
SANDMAN L, 1995, J INF DIS S1, V171, P550
[25]  
SANTAGOSTINO E, 1994, THROMB HAEMOSTASIS, V72, P508
[26]  
SCHEIFELE DW, 1993, CAN MED ASSOC J, V148, P551
[27]   ATYPICAL CLINICAL MANIFESTATIONS OF HEPATITIS-A [J].
SCHIFF, ER .
VACCINE, 1992, 10 :S18-S20
[28]   CLINICAL-TRIAL WITH INACTIVATED HEPATITIS-A VACCINE AND RECOMMENDATIONS FOR ITS USE [J].
TILZEY, AJ ;
PALMER, SJ ;
BARROW, S ;
PERRY, KR ;
TYRRELL, H ;
SAFARY, A ;
BANATVALA, JE .
BMJ-BRITISH MEDICAL JOURNAL, 1992, 304 (6837) :1272-1276
[29]   INACTIVATED HEPATITIS-A VACCINE - REACTOGENICITY, IMMUNOGENICITY, AND LONG-TERM ANTIBODY PERSISTENCE [J].
VANDAMME, P ;
THOELEN, S ;
CRAMM, M ;
DEGROOTE, K ;
SAFARY, A ;
MEHEUS, A .
JOURNAL OF MEDICAL VIROLOGY, 1994, 44 (04) :446-451
[30]   SINGLE-DOSE INACTIVATED HEPATITIS-A VACCINE - RATIONALE AND CLINICAL-ASSESSMENT OF THE SAFETY AND IMMUNOGENICITY [J].
VANDAMME, P ;
THOELEN, S ;
MEHEUS, A ;
SAFARY, A ;
ANDRE, FE ;
MATHEI, C .
JOURNAL OF MEDICAL VIROLOGY, 1994, 44 (04) :435-441