Clinical Trial: Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)

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

Official Title: Randomised, Double-blind, Phase II Evaluation of the Safety and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE) and Yellow Fever

Brief Summary:

The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.

Objectives:

Safety:

  • Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE administered concurrently, one month before or one month after STAMARIL® to adult volunteers (≥ 18 to ≤ 55 years) without prior Japanese encephalitis (JE) or yellow fever (YF) vaccination.

Immunogenicity:

  • Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE administered concurrently, one month before or one month after STAMARIL® to adult volunteers without prior JE (or YF) vaccination.
  • Assess the durability of the immune response in adult volunteers 6 months after administration of ChimeriVax™-JE and STAMARIL®.

Detailed Summary: All participants will receive two injections, one to each arm on Days 0 and 30, respectively. Immunogenicity will be tested on Days 0, 15, 30, 45, and 60, and at Month 6.
Sponsor: Sanofi

Current Primary Outcome:

  • Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. [ Time Frame: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60) ]

    Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples.

    The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

  • Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination. [ Time Frame: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60) ]

    Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising an

    Original Primary Outcome:

    • To provide information concerning the immunogenicity of ChimeriVax™-JE and STAMARIL® after co-administration or sequential vaccination. [ Time Frame: Day 30 after each dose ]
    • To provide information concerning the safety after co-administration or sequential administration of ChimeriVax™-JE and STAMARIL®. [ Time Frame: 0-30 days after each dose and entire study duration ]


    Current Secondary Outcome:

    • Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. [ Time Frame: Day 0 through 6 months post-vaccination ]

      Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test.

      Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)

    • Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo [ Time Frame: Day 0 through 6 months post-vaccination ]

      Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test.

      Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).



    Original Secondary Outcome: Assess the durability of the immune response in adult volunteers 6 months after administration of ChimeriVax™-JE and STAMARIL®. [ Time Frame: 6 months post-vaccination ]

    Information By: Sanofi

    Dates:
    Date Received: September 21, 2009
    Date Started: July 2004
    Date Completion:
    Last Updated: September 18, 2012
    Last Verified: September 2012