Phase 1/2 Lyme Vaccine Study

Tracking Information
First Submitted Date ICMJE	December 22, 2011
First Posted Date ICMJE	January 5, 2012
Last Update Posted Date	October 23, 2017
Study Start Date ICMJE	March 2011
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 3, 2012)	Antibody response to the vaccine [ Time Frame: 28 days after the third vaccination (= Day 85) ]; Frequency and severity of injection site and systemic reactions [ Time Frame: Within 7 days after each vaccination (i.e. Days 8, 36 and 64) ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01504347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 24, 2013)	Antibody response [ Time Frame: At baseline, 28 days after each vaccination (i.e. Days 29, 57 and 85), 180 and 270 days after the first vaccination (Day 181, Day 271) and 180 days after the booster vaccination (Day 361 or Day 451 - 546) ]; Fold increase in antibody titer compared to baseline [ Time Frame: 28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination ]; Seroconversion rate (at least 4-fold increase of each rOspA type-specific Immunoglobulin G (IgG) titer) as compared to baseline [ Time Frame: 28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination ]; Frequency and severity of adverse events [ Time Frame: 28 days after each vaccination and during entire study period ]
Original Secondary Outcome Measures ICMJE; (submitted: January 3, 2012)	Antibody response [ Time Frame: At baseline, 28 days after each vaccination (i.e. Days 29, 57 and 85), 180 and 270 days after the first vaccination (Day 181, Day 271) and 180 days after the booster vaccination (Day 361 or Day 451 - 546) ]; Fold increase in antibody titer compared to baseline [ Time Frame: 28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination ]; Seroconversion rate (at least 4-fold increase of each rOspA type-specific IgG titer) as compared to baseline [ Time Frame: 28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination ]; Frequency and severity of adverse events [ Time Frame: 28 days after each vaccination and during entire study period ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase 1/2 Lyme Vaccine Study
Official Title ICMJE	Randomized, Double-Blind, Phase 1/2 Clinical Study to Investigate the Safety and Immunogenicity of a Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) in Healthy Subjects Aged 18 to 70 Years
Brief Summary	Section 1: The purpose of the study is to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study. Section 2: An additional purpose of the study is to evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition ICMJE	Prophylaxis of Lyme Borreliosis
Intervention ICMJE	Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine Primary vaccination (6 study arms of 50 subjects each): 3 intramuscular injections containing either dose A, B or C in an adjuvanted or non-adjuvanted formulation (6 different formulations) given in monthly intervals (recruited in 3 sequential cohorts); Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine Booster vaccination 9-12 months after first vaccination in Section 1 subjects; Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine 3 intramuscular injections at monthly intervals (using 2 formulations selected from Section 1) in seronegative and seropositive subjects (N=350) and a booster vaccination at 6 months or at 9-12 months (Cohorts 4: seronegatives; Cohort 5: seropositives)
Study Arms	Experimental: Primary vaccination in seronegative subjects Intervention: Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine; Experimental: Booster vaccination in seronegative subjects Intervention: Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine; Experimental: Primary + booster vacc. (seronegative + seropositive subjects) Intervention: Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine
Publications *	Wressnigg N, Barrett PN, Pöllabauer EM, O'Rourke M, Portsmouth D, Schwendinger MG, Crowe BA, Livey I, Dvorak T, Schmitt B, Zeitlinger M, Kollaritsch H, Esen M, Kremsner PG, Jelinek T, Aschoff R, Weisser R, Naudts IF, Aichinger G. A Novel multivalent OspA vaccine against Lyme borreliosis is safe and immunogenic in an adult population previously infected with Borrelia burgdorferi sensu lato. Clin Vaccine Immunol. 2014 Nov;21(11):1490-9. doi: 10.1128/CVI.00406-14. Epub 2014 Sep 3.; Wressnigg N, Pöllabauer EM, Aichinger G, Portsmouth D, Löw-Baselli A, Fritsch S, Livey I, Crowe BA, Schwendinger M, Brühl P, Pilz A, Dvorak T, Singer J, Firth C, Luft B, Schmitt B, Zeitlinger M, Müller M, Kollaritsch H, Paulke-Korinek M, Esen M, Kremsner PG, Ehrlich HJ, Barrett PN. Safety and immunogenicity of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomised, dose-escalation phase 1/2 trial. Lancet Infect Dis. 2013 Aug;13(8):680-9. doi: 10.1016/S1473-3099(13)70110-5. Epub 2013 May 10.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 24, 2013)	1630
Original Estimated Enrollment ICMJE; (submitted: January 3, 2012)	650
Actual Study Completion Date	February 2014
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Main Inclusion Criteria: Subject is 18 to 70 years old at the time of screening; Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry; Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination; If female of childbearing potential, presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study Additional inclusion criterion for seropositive subjects in Section 2 only: - Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry Main Exclusion Criteria: Subject has a physician-diagnosed chronic illness related to Lyme borreliosis (LB) or active LB; Subject has been treated for LB with antibiotics within 3 months of study entry; Subject had a tick bite within 3 weeks prior to screening or first vaccination; Subject has a history or active infection with Babesia microti (babesiosis) or Anaplasma phagocytophilum (ehrlichiosis); Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder; Subject has clinically significant abnormal laboratory values at screening; Subject currently has or has a history of immunodeficiency; Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response.; Subject has a history of anaphylaxis or severe allergic reactions; Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study; Subject is pregnant or lactating at the time of study enrollment Additional exclusion criterion for subjects in Section 1 and seronegative subjects in Section 2: - Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Austria, Germany
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01504347
Other Study ID Numbers ICMJE	730901; 2010-023384-18 ( EudraCT Number )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Shire ( Baxalta now part of Shire )
Study Sponsor ICMJE	Baxalta now part of Shire
Collaborators ICMJE	Baxter Innovations GmbH
Investigators ICMJE	Study Director: Eva Maria Pöllabauer, MD Baxter Innovations GmbH
PRS Account	Shire
Verification Date	March 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP