title: A Novel multivalent OspA vaccine against Lyme borreliosis is safe and immunogenic in an adult population previously infected with Borrelia burgdorferi sensu lato.
abstract: Lyme borreliosis (LB) patients who recover, as well as previously infected asymptomatic individuals, remain vulnerable to reinfection with Borrelia burgdorferi sensu lato. There is limited information available about the use of OspA vaccines in this population. In this study, a randomized double-blind phase I/II trial was performed to investigate the safety and immunogenicity of a novel multivalent OspA vaccine in healthy adults who were either seronegative or seropositive for previous B. burgdorferi sensu lato infection. The participants received three monthly priming immunizations with either 30 μg or 60 μg alum-adjuvanted OspA antigen and a booster vaccination either 6 months or 9 to 12 months after the first immunization. The antibody responses to the six OspA serotypes included in the vaccine were evaluated. Adverse events were predominantly mild and transient and were similar in the seronegative and seropositive populations. Substantial enzyme-linked immunosorbent assay (ELISA) and surface-binding antibody responses against all six OspA antigens were induced after the primary immunization schedule in both populations, and they were substantially increased with both booster schedules. The antibody responses induced by the two doses were similar in the seronegative population, but there was a significant dose response in the seropositive population. These data indicate that the novel multivalent OspA vaccine is well tolerated and immunogenic in individuals previously infected with B. burgdorferi sensu lato. (This study is registered at ClinicalTrials.gov under registration no. NCT01504347.).
authors.affiliation: Vaccine R&D, Baxter BioScience, Vienna, Austria nina_wressnigg@baxter.com.
authors.forename: Nina
authors.initials: N
authors.lastname: Wressnigg
authors.affiliation: Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.
authors.forename: P Noel
authors.initials: PN
authors.lastname: Barrett
authors.affiliation: Vaccine R&D, Baxter BioScience, Vienna, Austria.
authors.forename: Eva-Maria
authors.initials: EM
authors.lastname: Pöllabauer
authors.affiliation: Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.
authors.forename: Maria
authors.initials: M
authors.lastname: O'Rourke
authors.affiliation: Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.
authors.forename: Daniel
authors.initials: D
authors.lastname: Portsmouth
authors.affiliation: Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Schwendinger
authors.affiliation: Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.
authors.forename: Brian A
authors.initials: BA
authors.lastname: Crowe
authors.affiliation: Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.
authors.forename: Ian
authors.initials: I
authors.lastname: Livey
authors.affiliation: Global R&D, Baxter BioScience, Vienna, Austria.
authors.forename: Thomas
authors.initials: T
authors.lastname: Dvorak
authors.affiliation: Health Center Mainz, Mainz, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Schmitt
authors.affiliation: Medical University of Vienna, Vienna, Austria.
authors.forename: Markus
authors.initials: M
authors.lastname: Zeitlinger
authors.affiliation: Medical University of Vienna, Vienna, Austria.
authors.forename: Herwig
authors.initials: H
authors.lastname: Kollaritsch
authors.affiliation: University of Tübingen Institute of Tropical Medicine, Tübingen, Germany.
authors.forename: Meral
authors.initials: M
authors.lastname: Esen
authors.affiliation: University of Tübingen Institute of Tropical Medicine, Tübingen, Germany.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kremsner
authors.affiliation: Berlin Center for Travel and Tropical Medicine, Berlin, Germany.
authors.forename: Tomas
authors.initials: T
authors.lastname: Jelinek
authors.affiliation: Klinik und Polikinik für Dermatologie Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Aschoff
authors.affiliation: Hautarztpraxis Cutanis, Freiburg, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Weisser
authors.affiliation: Private practice, Rodgau, Germany.
authors.forename: Ingomar F K
authors.initials: IF
authors.lastname: Naudts
authors.affiliation: Vaccine R&D, Baxter BioScience, Vienna, Austria.
authors.forename: Gerald
authors.initials: G
authors.lastname: Aichinger
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000368:Aged; D000534:Alum Compounds / Q000008:administration & dosage; D000907:Antibodies, Bacterial / Q000097:blood; D000954:Antigens, Surface / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D001425:Bacterial Outer Membrane Proteins / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D015748:Borrelia burgdorferi Group / Q000276:immunology*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008074:Lipoproteins / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008193:Lyme Disease / Q000276:immunology* / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000534:Alum Compounds; D000907:Antibodies, Bacterial; D000954:Antigens, Surface; D001425:Bacterial Outer Membrane Proteins; D001428:Bacterial Vaccines; D008074:Lipoproteins; C072045:OspA protein; C041524:aluminum sulfate