title: Safety and immunogenicity of an outer surface protein A vaccine in subjects with previous Lyme disease.
abstract: The safety and immunogenicity of a recombinant outer surface protein A (OspA) Lyme vaccine in patients previously diagnosed with Lyme disease was assessed in a dose-ranging, prospective study. Thirty healthy volunteers were consecutively assigned to receive three doses of 3, 10, or 30 micrograms of OspA vaccine at 0, 1, and 2 months. Subjects were seen 3 days after each vaccine dose and 1 month after completion of the three-dose schedule. Local side effects included soreness, induration, swelling, and redness. Transient systemic side effects occurred in 21 subjects, the majority of which (81%) were characterized as mild. Solicited symptoms included migratory mild arthralgias that lasted 24 h in 3 subjects. Side effects were not more evident after the second or third dose. Of the patients, 93% developed high-titer OspA antibodies. Thus, an OspA vaccine may be safe and immunogenic in patients with a history of Lyme disease.
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
authors.forename: R T
authors.initials: RT
authors.lastname: Schoen
authors.forename: F
authors.initials: F
authors.lastname: Meurice
authors.forename: C M
authors.initials: CM
authors.lastname: Brunet
authors.forename: S
authors.initials: S
authors.lastname: Cretella
authors.forename: D S
authors.initials: DS
authors.lastname: Krause
authors.forename: J E
authors.initials: JE
authors.lastname: Craft
authors.forename: E
authors.initials: E
authors.lastname: Fikrig
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D000917:Antibody Formation; D000954:Antigens, Surface / Q000276:immunology* / Q000633:toxicity*; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology* / Q000633:toxicity*; D001428:Bacterial Vaccines / Q000276:immunology* / Q000633:toxicity; D015748:Borrelia burgdorferi Group / Q000276:immunology*; D004305:Dose-Response Relationship, Drug; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007115:Immunization Schedule; D007074:Immunoglobulin G / Q000097:blood; D008074:Lipoproteins; D008193:Lyme Disease / Q000276:immunology*; D011446:Prospective Studies; D012449:Safety; D014614:Vaccines, Synthetic / Q000276:immunology* / Q000633:toxicity*
chemical_list: D000907:Antibodies, Bacterial; D000954:Antigens, Surface; D001425:Bacterial Outer Membrane Proteins; D001428:Bacterial Vaccines; D007074:Immunoglobulin G; D008074:Lipoproteins; C072045:OspA protein; D014614:Vaccines, Synthetic