Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders

Summary

Hepatitis B is a vaccine preventable infection which can be transmitted through occupational exposure. Approximately 15% of patients will not respond to an initial series of vaccination. Of those re-vaccinated approximately fifty percent will respond. On the basis of poor response to a third series, repeat vaccination is not recommended and non-responders are considered vulnerable to infection. Cardell studied the use of double dose combination hepatitis A and B vaccine (Twinrix) in non responders who had received four or more doses previously and found a high response rate suggesting this vaccine and dose could be effective. The investigators study seeks to duplicate the findings of Cardell, using a more strict definition of non-responder (6 or more previous doses).

Timeline

Start

2010-04

Primary completion

2011-06

Completion

2011-07

Publications

• Background Cardell K, Akerlind B, Sallberg M, Fryden A. Excellent response rate to a double dose of the combined hepatitis A and B vaccine in previous nonresponders to hepatitis B vaccine. J Infect Dis. 2008 Aug 1;198(3):299-304. doi: 10.1086/589722.
• Background Alavian SM, Mansouri S, Abouzari M, Assari S, Bonab MS, Miri SM. Long-term efficacy of hepatitis B vaccination in healthcare workers of Oil Company Hospital, Tehran, Iran (1989-2005). Eur J Gastroenterol Hepatol. 2008 Feb;20(2):131-4. doi: 10.1097/MEG.0b013e3282f1cc28.
• Background Chen W, Gluud C. Vaccines for preventing hepatitis B in health-care workers. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD000100. doi: 10.1002/14651858.CD000100.pub3.
• Background Clemens R, Sanger R, Kruppenbacher J, Hobel W, Stanbury W, Bock HL, Jilg W. Booster immunization of low- and non-responders after a standard three dose hepatitis B vaccine schedule--results of a post-marketing surveillance. Vaccine. 1997 Mar;15(4):349-52. doi: 10.1016/s0264-410x(96)00205-8.
• Background Craven DE, Awdeh ZL, Kunches LM, Yunis EJ, Dienstag JL, Werner BG, Polk BF, Syndman DR, Platt R, Crumpacker CS, et al. Nonresponsiveness to hepatitis B vaccine in health care workers. Results of revaccination and genetic typings. Ann Intern Med. 1986 Sep;105(3):356-60. doi: 10.7326/0003-4819-105-3-356.
• Background Czeschinski PA, Binding N, Witting U. Hepatitis A and hepatitis B vaccinations: immunogenicity of combined vaccine and of simultaneously or separately applied single vaccines. Vaccine. 2000 Jan 6;18(11-12):1074-80. doi: 10.1016/s0264-410x(99)00354-0.
• Background Das K, Gupta RK, Kumar V, Kar P. Immunogenicity and reactogenicity of a recombinant hepatitis B vaccine in subjects over age of forty years and response of a booster dose among nonresponders. World J Gastroenterol. 2003 May;9(5):1132-4. doi: 10.3748/wjg.v9.i5.1132.
• Background Goldwater PN. Randomized comparative trial of interferon-alpha versus placebo in hepatitis B vaccine non-responders and hyporesponders. Vaccine. 1994 Apr;12(5):410-4. doi: 10.1016/0264-410x(94)90116-3.
• Background Goldwater PN. Randomized, comparative trial of 20 micrograms vs 40 micrograms Engerix B vaccine in hepatitis B vaccine non-responders. Vaccine. 1997 Mar;15(4):353-6. doi: 10.1016/s0264-410x(96)00202-2.
• Background Jacques P, Moens G, Desombere I, Dewijngaert J, Leroux-Roels G, Wettendorff M, Thoelen S. The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population. Vaccine. 2002 Nov 1;20(31-32):3644-9. doi: 10.1016/s0264-410x(02)00397-3.
• Background Rendi-Wagner P, Shouval D, Genton B, Lurie Y, Rumke H, Boland G, Cerny A, Heim M, Bach D, Schroeder M, Kollaritsch H. Comparative immunogenicity of a PreS/S hepatitis B vaccine in non- and low responders to conventional vaccine. Vaccine. 2006 Apr 5;24(15):2781-9. doi: 10.1016/j.vaccine.2006.01.007. Epub 2006 Jan 19.
• Background Rottinghaus ST, Poland GA, Jacobson RM, Barr LJ, Roy MJ. Hepatitis B DNA vaccine induces protective antibody responses in human non-responders to conventional vaccination. Vaccine. 2003 Nov 7;21(31):4604-8. doi: 10.1016/s0264-410x(03)00447-x.
• Background U.S. Public Health Service. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR Recomm Rep. 2001 Jun 29;50(RR-11):1-52.
• Background Westmoreland D, Player V, Heap DC, Hammond A. Immunization against hepatitis B--what can we expect? Results of a survey of antibody response to immunization in persons 'at risk' of occupational exposure to hepatitis B. Epidemiol Infect. 1990 Jun;104(3):499-509. doi: 10.1017/s0950268800047506.
• Background Wismans P, van Hattum J, Stelling T, Poel J, de Gast GC. Effect of supplementary vaccination in healthy non-responders to hepatitis B vaccination. Hepatogastroenterology. 1988 Apr;35(2):78-9.
• Background Yasumura S, Shimizu Y, Yasuyama T, Hiroki O, Okada K, Tsukishiro T, Tsuchida T, Higuchi K, Watanabe A. Intradermal hepatitis B virus vaccination for low- or non-responded health-care workers. Acta Med Okayama. 1991 Dec;45(6):457-9. doi: 10.18926/AMO/32181.
• Background Zuckerman JN, Zuckerman AJ, Symington I, Du W, Williams A, Dickson B, Young MD; UK Hepacare Study Group. Evaluation of a new hepatitis B triple-antigen vaccine in inadequate responders to current vaccines. Hepatology. 2001 Oct;34(4 Pt 1):798-802. doi: 10.1053/jhep.2001.27564.

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