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Phase 1/2 Lyme Vaccine Study

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ClinicalTrials.gov Identifier: NCT01504347
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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 *

*   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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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