Safety and immunogenicity of an outer surface protein A vaccine in subjects with previous Lyme disease.
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.
Schoen
R T
RT
Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
Meurice
F
F
Brunet
C M
CM
Cretella
S
S
Krause
D S
DS
Craft
J E
JE
Fikrig
E
E
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*
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