Immunogenicity of recombinant hepatitis B vaccine in dialysis patients |
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| Authors: | W Jilg M Schmidt B Weinel T Küttler H Brass J Bommer R Müller B Schulte A Schwarzbeck F Deinhardt |
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| Affiliation: | 1. Max von Pettenkofer Institute for Hygiene and Medical Microbiology, University of Munich, Munich, (F.R.G.);2. City Hospitals, Ludwigshafen am Rhein, (F.R.G.);2. Department of Medicine, University of Heidelberg, Heidelberg, (F.R.G.);3. School of Medicine, Hanover, (F.R.G.);4. Hospital for Kidney and High Blood Pressure Diseases, Hanover (F.R.G.);1. Academic Department of Gastroenterology, Athens University Medical School, Laiko General Hospital, Athens, Greece;2. Department of Medicine and Therapeutics and Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong Special Administrative Region;3. Department of Gastroenterology & Hepatology, Erasmus MC University Hospital, Rotterdam, The Netherlands;4. Francis Family Liver Clinic, Toronto Western & General Hospital, Division of Gastroenterology, University of Toronto, Toronto, Canada;5. 1st Division of Gastroenterology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy;1. Merck & Co., Inc., Whitehouse Station, NJ, United States;2. Fondazione “S. Maugeri” I.R.C.C.S. Medical Center, Pavia, Italy;1. School of Public Health, Shanxi Medical University, Taiyuan 030001, Shanxi, China;2. Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan 030001, Shanxi, China;3. Department of Pathology, the First Hospital, Shanxi Medical University, Taiyuan 030001, Shanxi, China;4. Heping Hospital Affiliated to Changzhi Medical College, Changzhi 046000, Shanxi, China;5. Linfen Central Hospital, 041000 Shanxi, China;6. Linfen People’s Hospital, 041000 Shanxi, China;7. Yuncheng Central Hospital, 044000 Shanxi, China;8. The Second People’s Hospital of Jinzhong, 030600 Shanxi, China;9. Fenyang Hospital of Shanxi Province, 032200 Shanxi, China;10. The hospital of Traditional Chinese Medicine in Changzhi, Changzhi 046000, Shanxi, China;11. Yale School of Public Health, New Haven 06510, CT, USA;12. Chinese Preventive Medicine Association, Beijing 100021, China |
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| Abstract: | Eighty-eight dialysis patients were vaccinated with recombinant hepatitis B vaccine prepared in yeast. Fourty-nine patients were immunized 3 times (months 0, 1, 6) intragluteally with 40 micrograms hepatitis B surface antigen (HBsAg) per dose. Only 32 of them (65.3%) showed anti-HBs concentrations above 10 IU/l with a geometric mean titer (GMT) of 180.7 IU/l after 3 vaccinations, whereas all of the 16 healthy controls, vaccinated 3 times with a 10-micrograms dose of the same vaccine batch, had specific antibodies higher than 10 IU/l (GMT 897.4 IU/l). Responses of patients were slightly higher than those of dialysis patients vaccinated in an earlier study with plasma-derived vaccine according to the same schedule. Results in 20 patients immunized 6 times intragluteally with 40 micrograms HBsAg/dose in monthly intervals were not better (at month 7, 65% showed anti-HBs concentrations greater than 10 IU/l; GMT = 126.6 IU/l), and 19 patients receiving 6 times 20 micrograms HBsAg monthly showed significantly lower responses (anti-HBs greater than 10 IU/l in 42% of vaccinees, GMT = 89.5 IU/l). The vaccine was tolerated well; side-effects were slight, and no serious adverse reactions were observed. In conclusion, recombinant hepatitis B vaccine is comparable to plasma-derived vaccine also in the case of dialysis patients; a 6-dose schedule does not seem to have much advantage compared to the conventional 3-dose regimen. |
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