Safety and immunogenicity of an outer surface protein A vaccine in subjects with previous Lyme disease

J Infect Dis. 1995 Nov;172(5):1324-9. doi: 10.1093/infdis/172.5.1324.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Antibodies, Bacterial / blood
  • Antibody Formation
  • Antigens, Surface / immunology*
  • Antigens, Surface / toxicity*
  • Bacterial Outer Membrane Proteins / immunology*
  • Bacterial Outer Membrane Proteins / toxicity*
  • Bacterial Vaccines / immunology*
  • Bacterial Vaccines / toxicity
  • Borrelia burgdorferi Group / immunology*
  • Dose-Response Relationship, Drug
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Immunization Schedule
  • Immunoglobulin G / blood
  • Lipoproteins*
  • Lyme Disease / immunology*
  • Prospective Studies
  • Safety
  • Vaccines, Synthetic / immunology*
  • Vaccines, Synthetic / toxicity*


  • Antibodies, Bacterial
  • Antigens, Surface
  • Bacterial Outer Membrane Proteins
  • Bacterial Vaccines
  • Immunoglobulin G
  • Lipoproteins
  • OspA protein
  • Vaccines, Synthetic