2003
An open-label, nonrandomized, single-center, prospective extension, clinical trial of booster dose schedules to assess the safety profile and immunogenicity of recombinant outer-surface protein A (OspA) Lyme disease vaccine
Schoen RT, Deshefy-Longhi T, Van-Hoecke C, Buscarino C, Fikrig E. An open-label, nonrandomized, single-center, prospective extension, clinical trial of booster dose schedules to assess the safety profile and immunogenicity of recombinant outer-surface protein A (OspA) Lyme disease vaccine. Clinical Therapeutics 2003, 25: 210-224. PMID: 12637121, DOI: 10.1016/s0149-2918(03)90027-0.Peer-Reviewed Original ResearchConceptsLyme disease vaccineFirst booster doseSecond booster doseBooster doseAdverse eventsBooster dosesPrimary seriesMonth 24Disease vaccineClinical trialsEfficacy trialsImmune responseIncidence of AEsPattern of AEsLyme diseaseMost adverse eventsGeometric mean titersTotal IgG antibodiesProportion of subjectsPositive test resultsSeroprotective levelsBooster vaccinationMonth 36Third vaccinationDiary cards
1998
Vaccination against Lyme Disease with Recombinant Borrelia burgdorferi Outer-Surface Lipoprotein A with Adjuvant
Steere A, Sikand V, Meurice F, Parenti D, Fikrig E, Schoen R, Nowakowski J, Schmid C, Laukamp S, Buscarino C, Krause D. Vaccination against Lyme Disease with Recombinant Borrelia burgdorferi Outer-Surface Lipoprotein A with Adjuvant. New England Journal Of Medicine 1998, 339: 209-215. PMID: 9673298, DOI: 10.1056/nejm199807233390401.Peer-Reviewed Original ResearchConceptsLyme diseaseSerologic testingVaccine efficacyAsymptomatic infectionLipoprotein AInjections of vaccineOuter surface lipoprotein AB. burgdorferi infectionFirst yearPlacebo recipientsPlacebo groupVaccine groupVaccine recipientsStudy entryRandomized trialsSystemic reactionsThird injectionBurgdorferi infectionEffective vaccineSkin lesionsReaction testingVaccineDefinite casesDiseaseInfection
1995
Safety and Immunogenicity of an Outer Surface Protein A Vaccine in Subjects with Previous Lyme Disease
Schoen R, Meurice F, Brunet C, Cretella S, Krause D, Craft J, Fikrig E. Safety and Immunogenicity of an Outer Surface Protein A Vaccine in Subjects with Previous Lyme Disease. The Journal Of Infectious Diseases 1995, 172: 1324-1329. PMID: 7594671, DOI: 10.1093/infdis/172.5.1324.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, BacterialAntibody FormationAntigens, SurfaceBacterial Outer Membrane ProteinsBacterial VaccinesBorrelia burgdorferi GroupDose-Response Relationship, DrugEnzyme-Linked Immunosorbent AssayHumansImmunization ScheduleImmunoglobulin GLipoproteinsLyme DiseaseProspective StudiesSafetyVaccines, SyntheticConceptsSide effectsLyme diseaseOspA vaccinePrevious Lyme diseaseThree-dose scheduleLocal side effectsSystemic side effectsLyme vaccineMild arthralgiaVaccine doseThird doseProspective studyOspA antibodiesHealthy volunteersOuter surface proteinsVaccinePatientsDiseaseImmunogenicityDoseMonthsSubjectsSurface proteinsSafetyArthralgia