Lyme disease vaccine

Haemophilus influenzae type b conjugate and hepatitis B vaccine he -maw-fil-us in-flu-en -zah kon-jew -gate hep -ah-tie -tus bee-vak -seen Lyme disease vaccine (recombinant OspA) lime-vak -seen... 

LYMErix Lyme disease vaccine GlaxoSmithKline Active immunization against Lyme disease... 

Lymerix (rOspA, a lipoprotein found on the surface of Borrelia burgdorferi, the major causative agent of Lyme s disease. Produced in E. coli) SmithKline Beecham Lyme disease vaccine 1998 (USA)... 

C. Buscarino, and D.S. Krause, Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. Lyme Disease Vaccine Study Group. N Engl J Med, 1998. 339(4) 209-15. 

Lyme disease vaccine (recombinant OspA), acylated... 

LYMErix (OspA) Lyme disease vaccine xE.coli... 

Lyme disease vaccine LymErix (GlaxoSK) Prevention of Lyme disease... 

In December 1998, based on many prehcensure clinical trials, the first Lyme disease vaccine (LYMErix, manufactured by the then SmithKline Beecham) was hcensed by the Food and Drug Administration (FDA) for individuals aged 15-70 years old (1) and subsequently became commercially available in the USA. In 1999, the Advisory Committee on Immunization Practices (ACIP) made recommendations for Lyme disease vaccine (2), including data on efficacy and safety (SEDA-23, 338). No convincing evidence was found that the vaccine caused serious problems, but discussion about its safety continued and... 

In another randomized, double-blind trial in 10 936 subjects in areas of the USA in which Ljme disease is endemic, either recombinant B. burgdorferi OspA with adjuvant or placebo was given initially and at 1 and 12 months (9). After two injections, 22 subjects given vaccine and 43 given placebo contracted definite Lyme disease vaccine efficacy was 49% (95% Cl = 15, 69%). In the second... 

Suspicions were expressed in the Mealey Publication s Drug and Medical Device Report that the Lyme disease vaccine LYMErix could cause an incurable form of autoimmune arthritis. It was hjrpothesized that blood concentrations of OspA after three doses of vaccine place vaccinees classified by genetic type HLA-DR4-I- at risk of developing treatment-resistant Ljme arthritis. The premarket trials for the vaccine were assessed by an independent advisory committee, which found no link between Ljme disease immunization and autoimmune arthritis (10). However, the committee stressed the need for long-term surveillance and further studies in those over 70 years and in children, and the effect of the vaccine in patients with chronic arthritis the possible development of autoimmunity deserves further study (11). After licensing of the vaccine, more than 1 rmlfion Americans received it and no unusual adverse effects were reported to the manufacturer (10). 

From reports containing information on HLA types, clinical descriptions of adverse events in those given Lyme disease vaccine are similar in people with DR4 and non-DR4 HLA haplotypes and do not suggest more inflammatory arthritis in people of DR4 haplotype (15) [http //www.fda.gOv/ohrms/dockets/ac/01/briefing/3680b2-06.pdf]. The characteristics of adverse events in people with a self-reported history of Lyme disease do not differ substantially from all adverse events after Lyme... 

Anonymous. Lyme disease vaccine. Med Lett Drugs Ther 1999 41(1049) 29-30. 

Advisory Committee on Immunization Practices (ACIP). Recommendations for the use of Lyme disease vaccine. MMWR Recomm Rep 1999 48(RR-7) 1-17, 21-5. 

Thanassi WT, Schoen RT. The Lyme disease vaccine conception, development, and implementation. Ann Intern Med 2000 132(8) 661-8. 

Onrust SV, Goa KL. Adjuvanted Lyme disease vaccine a review of its use in the management of Lyme disease. Drugs 2000 59(2) 281-99. 

FDA. Vaccines and Related Biological Products Advisory Committee. LYMErix. Lyme Disease Vaccine Safety Update, 31 January 2001. http7/www.fda.gov/ohrms/dockets / ac/01/briefing/368ob2.htm (accessed 10 February 2001). 

Sigal LH, Zahradnik JM, Lavin P, Patella SJ, Bryant G, Haselby R, Hilton E, Kunkel M, Adler-BQein D, Doherty T, Evans J, MoUoy PJ, Seidner AL, Sabetta JR, Simon HJ, Klempner MS, Mays J, Marks D, Malawista SE. A vaccine consisting of recombinant BorreUa burgdorferi outer-surface protein A to prevent Lyme disease. Recombinant Outer-Surface Protein A Lyme Disease Vaccine Study Consortium. N Engl J Med 1998 339(4) 216-22. 

Marwick C. Guarded endorsement for Lyme disease vaccine. JAMA 1998 279(24) 1937-8. 

Schoen RT, Sikand VK, Caldwell MC, Van Hoecke C, GUlet M, Buscarino C, Parent DL. Safety and inununo-genicity profile of a recombinant outer-surface protein A Lyme disease vaccine clinical trial of a 3-dose schedule at 0,1, and 2 months. Clin Ther 2000 22(3) 315-25. 

Ball R, Shadomy SV, Meyer A, Huber BT, Leffell MS, Zachary A, Belotto M, Hilton E, Bryant-Genevier M, Schriefer ME, Miller FW, Braun MM. HLA type and immune response to Borrelia burgdorferi outer surface protein a in people in whom arthritis developed after Lyme disease vaccination. Arthritis Rheum. 2009 60(4) 1179-1186. 

In the mid-1990s, an effective vaccine against Lyme disease was developed. However, soon after it was brought to market there were claims that the vaccine caused serious side effects including a form of arthritis. While the merits of this claim were debated, sales of the vaccine decreased significantly and the manufacturer withdrew it from the market in 2002. Research into a new Lyme disease vaccine is continuing and a new vaccine may be in the market in the near future. 

Lycopersicon cheesmanii 970 Lycopersicon esculentum 970 Lycopersicon pennellii 970 Lycopersicon pimpinellifolium 970 Lyme disease vaccine 18 Lymerix 18 Lypolex... 

There also is a marketed Lyme disease vaccine containing recombinant OspA (31,115,116). The vaccine is a sterile suspension of a noninfectious recombinant vaccine containing an immunodominant outer surface protein of Borrelia burgdorferi known as lipoprotein OspA. The antigen is adsorbed onto aluminum hydroxide as an adjuvant. Vaccine efficacy against definite Lyme disease is 78% after three doses. 

Souayah N, Ajroud-Driss S, Sander W, Brannagan TH, Hays AP, Chin RL. Small fiber neuropathy following vaccination for rabies, varicella or Lyme disease. Vaccine 2009 27 7322-5. 

---