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• W2144644148 abstract "The currently licensed hepatitis B vaccines, consisting of recombinant hepatitis B surface antigen (HBsAg) and alum, are highly effective and induce protective antibody titers in 95% of vaccinees after 3 immunizations. Therefore, testing of titers of antibody to HBsAg (anti-HBs) is performed only in high-risk populations (such as health care workers) or poor vaccine responders (such as patients undergoing dialysis). Although a 5% nonresponse rate among healthy vaccinees would appear to be a small percentage, in absolute terms it leads to a substantial number of individuals who may not be protected while working in a high-risk environment. Moreover, nonresponse is associated with considerable uncertainty and anxiety. How can the immunogenicity of the vaccine be increased for vaccine nonresponders? Several strategies have been studied in this population: higher vaccine dose [1], different mode of application (e.g., intradermal) [2], additional vaccinations [3], inclusion of additional antigens (such as pre-S1 and pre-S2) [4], and the use of more potent adjuvants [5]. Currently, a higher vaccine dose is recommended for immunocompromised patients, such as dialysis patients. Intradermal injections are technically demanding and allow the application of lower doses of vaccine only; this route has not been consistently shown to be superior to intramuscular injection. New vaccines incorporating additional portions of the HBsAg (such as pre-S1 and pre-S2) have been developed, and increased immunogenicity has been clearly demonstrated [4, 6]. Although one of these vaccines apparently has not been further developed, a second is currently available in Israel and East Asia and is still in clinical development in the United States and Europe. The use of a more potent adjuvant, monophosphoryl lipid A, has led to a vaccine that induces protective antibody titers in the majority of vaccinees after only 2 injections and that leads to a high response rate in prior nonresponders to the HBsAg vaccine formulated with alum [5]. In Europe, this vaccine is licensed for use in dialysis patients but has not yet been licensed for use in healthy vaccine nonresponders [7]. Another approach has been the addition of CpG oligonucleotides, which, via stimulation of Toll-like receptor (TLR) 9, activate innate immune responses to the standard alum formulation of HBsAg [8]. Again, higher and earlier anti-HBs titers were induced in vaccinees, with protective anti-HBs titers occurring in the majority of vaccinees after a single inoculation. However, a clinical trial of a different TLR9 agonist was halted in March 2008 by the US Food and Drug Administration, for safety concerns [9]. A major reason for this slow development may lie in the heated debate regarding the safety of the standard hepatitis B vaccine that occurred during the late 1990s, when concern about an association of the vaccine with multiple sclerosis was raised. Although only trends for such an association had been reported in studies from France and the United Kingdom, it was not until 2001 that a large casecontrol study from the United States refuted a causal relationship [10]. Manufacturers, however, may have been worried that such allegations could arise again if a more immunogenic vaccine were to be used in the general population, and against this background it may have appeared overambitious and unrewarding to further improve a vaccine that was already 95% effective. So, what can be offered to current hepatitis B vaccine nonresponders? Most guidelines recommend a repeated course of vaccinations with the standard hepatitis B vaccine [11]. This approach leads to protective antibody titers in 50%–100% Received 7 April 2008; accepted 8 April 2008; electronically published 10 June 2008. Potential conflicts of interest: none reported. Financial support: This work is part of the activities of the VIRGIL European Network of Excellence on Antiviral Drug Resistance, which is supported by a grant (LSHM-CT-2004503359) from the Priority 1 “Life Sciences, Genomics and Biotechnology for Health” Programme of the 6th Framework Programme of the European Union. Reprints or correspondence: Dr. Helmut Diepolder, Dept. of Medicine II, University of Munich, Klinikum Grosshadern, Marchioninistr. 15, Munich, Bavaria D-81377, Germany (Helmut.Diepolder@med.uni-muenchen.de). The Journal of Infectious Diseases 2008; 198:297– 8 © 2008 by the Infectious Diseases Society of America. All rights reserved. 0022-1899/2008/19803-0001$15.00 DOI: 10.1086/589721 E D I T O R I A L C O M M E N T A R Y" @default.
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• W2144644148 title "Can Specific Heterologous Immunity Boost Hepatitis B Vaccine Responses?" @default.
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