Trial record 1 of 1 for:    NCT01504347
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Phase 1/2 Lyme Vaccine Study

This study has been completed.
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01504347
First received: December 22, 2011
Last updated: March 25, 2014
Last verified: March 2014

December 22, 2011
March 25, 2014
March 2011
August 2011   (final data collection date for primary outcome measure)
  • Antibody response to the vaccine [ Time Frame: 28 days after the third vaccination (= Day 85) ] [ Designated as safety issue: No ]
  • Frequency and severity of injection site and systemic reactions [ Time Frame: Within 7 days after each vaccination (i.e. Days 8, 36 and 64) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01504347 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Time Frame: 28 days after each vaccination and during entire study period ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Time Frame: 28 days after each vaccination and during entire study period ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase 1/2 Lyme Vaccine Study
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Prophylaxis of Lyme Borreliosis
  • 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)
  • 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
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.
 
Completed
1630
February 2014
August 2011   (final data collection date for primary outcome measure)

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

Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT01504347
730901, 2010-023384-18
Yes
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Baxter Innovations GmbH
Study Director: Eva Maria Pöllabauer, MD Baxter Innovations GmbH
Baxter Healthcare Corporation
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP