Clinical Trial: Phase 1/2 Lyme Vaccine Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Vac

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 Summary:
Sponsor: Baxalta US Inc.

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: Baxalta US Inc.

Dates:
Date Received: December 22, 2011
Date Started: March 2011
Date Completion:
Last Updated: June 26, 2015
Last Verified: March 2014