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Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IC51
Sponsored by
Valneva Austria GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Japanese Encephalitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least 18 years of age
  • Written informed consent obtained prior to study entry
  • Subjects correctly included in and having completed study IC51-304 according to the protocol.

Exclusion Criteria:

  • Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period
  • Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
  • Pregnancy, lactation or unreliable contraception in female subjects

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    IC51

    Arm Description

    In study IC51-305, subjects who had received IC51 in study IC51-304 were tested for seroconversion 6 months after the first vaccination. Subjects who had protective titers were again tested for persistence of immunity at 12 months after the first immunization,whereas subjects who had titers below the seroconversion threshold by Month 6 received a booster dose of 1x6 mcg IC51 at Month 11. Their immune response was also assessed at Month 12. Thereafter, subjects who had no protective titer by Month 12 received a booster dose of 1x6 mcg IC51 at Month 23, regardless of prior treatment; and neutralizing antibody titers were reassessed at Month 24. Subjects who had protective titers at month 12 did not receive a booster at Month 23, and their neutralizing antibody titer was also assessed at Month 24.

    Outcomes

    Primary Outcome Measures

    Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination
    Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as: pos. (positive) (persistent): Subjects with a non-missing, pos. seroconversion at D56 (Study IC51-304) and without booster at M11 or M23 and with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and with non-missing, SP pos. PRNT50 at M24 neg. (negative) (non-persistent): Subjects with missing or neg. seroconversion at D56 (Study IC51-304) or booster at M11 or at M23, or non-missing, SP neg. PRNT50 at M6 or M12 or missing PRNT50 at both M6 and M12 or missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24

    Secondary Outcome Measures

    SPR 24 Months After the Primary Vaccination (Observed)
    Persistence of immunogenicity (SPR) at M24 (observed) defined as : positive (persistent): Subjects with a non-missing, positive seroconversion at D56 (Study IC51-304), and who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and with a non-missing, SP positive PRNT50 result at Visit 5 (M24) negative (non-persistent): Subjects with missing or negative seroconversion at D56 (Study IC51-304), or who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or with a non-missing, SP negative PRNT50 result at Visit 5 (M24)
    Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination
    Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination
    SCR 1 Month After the Booster Doses
    GMT 1month After Booster Doses
    Safety Profile of IC51

    Full Information

    First Posted
    January 4, 2008
    Last Updated
    February 5, 2014
    Sponsor
    Valneva Austria GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00595270
    Brief Title
    Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
    Official Title
    Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Valneva Austria GmbH

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose
    Detailed Description
    This is an open label, non-randomized multi-center phase 3 follow-up study. All volunteers having completed trial IC51-304 (NCT00595790) will be enrolled into this trial at 2 sites

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Japanese Encephalitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    349 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IC51
    Arm Type
    Other
    Arm Description
    In study IC51-305, subjects who had received IC51 in study IC51-304 were tested for seroconversion 6 months after the first vaccination. Subjects who had protective titers were again tested for persistence of immunity at 12 months after the first immunization,whereas subjects who had titers below the seroconversion threshold by Month 6 received a booster dose of 1x6 mcg IC51 at Month 11. Their immune response was also assessed at Month 12. Thereafter, subjects who had no protective titer by Month 12 received a booster dose of 1x6 mcg IC51 at Month 23, regardless of prior treatment; and neutralizing antibody titers were reassessed at Month 24. Subjects who had protective titers at month 12 did not receive a booster at Month 23, and their neutralizing antibody titer was also assessed at Month 24.
    Intervention Type
    Biological
    Intervention Name(s)
    IC51
    Other Intervention Name(s)
    Japanese Encephalitis purified inactivated vaccine
    Primary Outcome Measure Information:
    Title
    Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination
    Description
    Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as: pos. (positive) (persistent): Subjects with a non-missing, pos. seroconversion at D56 (Study IC51-304) and without booster at M11 or M23 and with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and with non-missing, SP pos. PRNT50 at M24 neg. (negative) (non-persistent): Subjects with missing or neg. seroconversion at D56 (Study IC51-304) or booster at M11 or at M23, or non-missing, SP neg. PRNT50 at M6 or M12 or missing PRNT50 at both M6 and M12 or missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24
    Time Frame
    - 24 months
    Secondary Outcome Measure Information:
    Title
    SPR 24 Months After the Primary Vaccination (Observed)
    Description
    Persistence of immunogenicity (SPR) at M24 (observed) defined as : positive (persistent): Subjects with a non-missing, positive seroconversion at D56 (Study IC51-304), and who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and with a non-missing, SP positive PRNT50 result at Visit 5 (M24) negative (non-persistent): Subjects with missing or negative seroconversion at D56 (Study IC51-304), or who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or with a non-missing, SP negative PRNT50 result at Visit 5 (M24)
    Time Frame
    24 months
    Title
    Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination
    Time Frame
    - 24 months
    Title
    Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination
    Time Frame
    24 months
    Title
    SCR 1 Month After the Booster Doses
    Time Frame
    1 month
    Title
    GMT 1month After Booster Doses
    Time Frame
    1 month
    Title
    Safety Profile of IC51
    Time Frame
    study duration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age Written informed consent obtained prior to study entry Subjects correctly included in and having completed study IC51-304 according to the protocol. Exclusion Criteria: Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period Immunodeficiency including post-organ-transplantation or immunosuppressive therapy Pregnancy, lactation or unreliable contraception in female subjects
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susanne Eder
    Organizational Affiliation
    Valneva Austria GmbH
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

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