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• W2093584758 abstract "I wholly concur with Raphael Stricker and Lorraine Johnson that attention to safety must be central to the development of any novel therapeutic agent. Comparative safety has certainly been an open topic of discussion with several second generation vaccines, such as those for acellular pertussis, rotavirus, and Japanese encephalitis, which were developed mainly because of safety concerns with their predecessors. This should no doubt be the case for novel Lyme disease vaccines, whether based on Borrelia burgdorferi outer surface protein A (OspA) or other antigens. My Comment was chiefly a discussion about the future of Lyme disease vaccination, and was intended neither as an autopsy nor eulogy of LYMErix. Nonetheless, I should reiterate that safety concerns about LYMErix were, in fact, never substantiated. Concerns about OspA vaccination arose from observations that HLA-DRB1*0401-positive individuals with antibiotic-refractory Lyme arthritis (following natural Lyme disease) have strong immune responses to OspA. Subsequent evidence does not substantiate the hypothesis that vaccination with OspA produces this same effect.1Steere AC Drouin EE Glickstein LJ Relationship between immunity to Borrelia burgdorferi outer-surface protein A (OspA) and Lyme arthritis.Clin Infect Dis. 2011; 52: s259-s265Crossref PubMed Scopus (56) Google Scholar Two clinical trials of the LYMErix vaccine, involving more than 21 000 participants, found that arthritis occurred at the same rate in both vaccine and placebo recipients.2Sigal LH Zahradnik JM Lavin P et al.A vaccine consisting of recombinant Borrelia burgdorferi outer-surface protein A to prevent Lyme disease.N Engl J Med. 1998; 339: 216-222Crossref PubMed Scopus (318) Google Scholar, 3Steere AC Sikand VK Meurice F et al.Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant.N Engl J Med. 1998; 339: 209-215Crossref PubMed Scopus (554) Google Scholar A secondary review of LYMErix by the US Food and Drug Administration in 2001 concluded that arthritis was no more frequent in vaccine recipients than in controls.4US Food and Drug AdministrationLYMErix Lyme disease vaccine, safety update.http://www.fda.gov/ohrms/dockets/ac/01/briefing/3680b2_02.pdfGoogle Scholar A 2002 examination of the vaccine adverse events reporting system found only 59 cases of arthritis out of 1·4 million vaccine recipients—this prevalence is indistinguishable from the background rate of arthritis in the general population.5Lathrop SL Ball R Haber P et al.Adverse event reports following vaccination for Lyme disease: December 1998–July 2000.Vaccine. 2002; 20: 1603-1608Crossref PubMed Scopus (69) Google Scholar In fact, placebo recipients in the two preapproval trials of the vaccine had a roughly 100-fold higher rate of arthritis. Stricker and Johnson's selection of small case series must be seen in this context. Case reports by their nature are epistemically incapable of showing causality or quantifying risk. Rare adverse events can, of course, be missed in preapproval trials. Since the lifespan of LYMErix was roughly that of a deer tick, one cannot be sure whether important safety concerns would have ultimately come to light. Nonetheless, the demise of LYMErix seems more to do with headaches at GlaxoSmithKline than with symptoms among its recipients. The phase 1/2 study reported by Nina Wressnigg and colleagues6Wressnigg N Pöllabauer E-M Aichinger G et al.Safety and immunogenicity of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomised, dose-escalation phase 1/2 trial.Lancet Infect Dis. 2013; 13: 680-689Summary Full Text Full Text PDF PubMed Scopus (51) Google Scholar found no major adverse events in 300 recipients of the OspA vaccine. This finding merits a cautious optimism that the future will hold a new option to safely prevent Lyme disease, a particularly resonant development in light of recent data from the Centers for Disease Control and Prevention suggesting that the disease affects hundreds of thousands of people a year. I declare that I have no conflicts of interest. Lyme disease vaccination: safety firstIn the Article by Nina Wressnigg and colleagues1 and the related Comment by Paul Lantos2 describing a novel Lyme vaccine, the authors attempt to avoid discussion of the side-effects of the previous Lyme vaccine, LYMErix (SmithKline Beecham, Pittsburgh, USA). This approach to safety issues bodes ill for the new Lyme vaccine candidate. Full-Text PDF Safety and immunogenicity of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomised, dose-escalation phase 1/2 trialThe novel multivalent OspA vaccine could be an effective intervention for prevention of Lyme borreliosis in Europe and the USA, and possibly worldwide. Larger confirmatory formulation studies will need to be done that include individuals seropositive for Borrelia burgdorferi sensu lato before placebo-controlled phase 3 efficacy studies can begin. Full-Text PDF" @default.
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• W2093584758 date "2014-01-01" @default.
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• W2093584758 title "Lyme disease vaccination: safety first – Author's reply" @default.
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