search
Back to results

A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) (THYB-03)

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Antigen (Ag85B-ESAT-6)
Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Sponsored by
Statens Serum Institut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring safety, immunogenicity, adjuvanted TB subunit vaccine

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male between 18 and 40 years old
  • TST negative groups: TST- and negative QuantiFERON-TB Gold In tube test
  • BCG group: known to be BCG-vaccinated > 2 years before(scar, vaccination card), TST+ (> 6 or any documented value > 6 mm on medical file in the past), with no active, chronic or past TB disease as confirmed by chest X ray, negative QuantiFERON-TB Gold In Tube test and negative 6-day lymphocyte tests.
  • Infection group: latent TB, TST+ ( = or > 10 mm or documented = or > 10 mm positive on medical file in the past), previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive QuantiFERON-TB Gold In Tube test and/or positive 6-day lymphocyte test.
  • Healthy based on medical examination/history at the inclusion
  • Signed informed consent
  • Prepared to grant authorized persons access to the medical records
  • The volunteer is likely to comply with instructions

Exclusion Criteria:

  • Confirmed active TB based on clinical evaluation(history, physical findings and investigations)
  • Vaccinated with any vaccine 3 months before first vaccination
  • Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins)
  • HBV, HCV or HIV sero-positive
  • Participation in other clinical trials
  • Known hypersensitivity to any of the vaccine components
  • Laboratory parameters outside of normal range considered clinically relevant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    12 TST negative volunteers antigen only

    12 TST negative volunteers

    12 BCG vaccinated volunteers

    12 with Latent TB infection >= 2 years ago

    Arm Description

    Outcomes

    Primary Outcome Measures

    Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry

    Secondary Outcome Measures

    Immunogenicity assessment by: A.Detection of IFN gama production after stimulation with Ag85B, ESAT-6 and H1. B.Detection of IgG antibodies to recombinant proteins Ag85B, ESAT-6 and H1 in serum/plasma.

    Full Information

    First Posted
    January 13, 2010
    Last Updated
    April 16, 2015
    Sponsor
    Statens Serum Institut
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01049282
    Brief Title
    A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
    Acronym
    THYB-03
    Official Title
    A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered in Different Antigen/Adjuvant Formulations in TST Negative and TST Positive Volunteers at 0 and 2 Months
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Statens Serum Institut

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study has the following objectives: Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.
    Detailed Description
    Number of trial subjects=48 Investigational product=Ag85B - ESAT-6 + IC31 Dosage Group 1: TST negative, 50 µg antigen Group 2: TST negative, 50 µg antigen + fixed adjuvant Group 3: BCG vaccinated, 50 µg antigen + fixed adjuvant Group 4 : Latent TB, 50 µg antigen + fixed adjuvant Dosage volume 0.5 ml Administration Intramuscularly into deltoid muscle, alternate arms at day 0 (right) and day 56 (left).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tuberculosis
    Keywords
    safety, immunogenicity, adjuvanted TB subunit vaccine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    12 TST negative volunteers antigen only
    Arm Type
    Experimental
    Arm Title
    12 TST negative volunteers
    Arm Type
    Experimental
    Arm Title
    12 BCG vaccinated volunteers
    Arm Type
    Experimental
    Arm Title
    12 with Latent TB infection >= 2 years ago
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Antigen (Ag85B-ESAT-6)
    Intervention Description
    Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
    Intervention Type
    Biological
    Intervention Name(s)
    Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
    Intervention Description
    Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
    Primary Outcome Measure Information:
    Title
    Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry
    Time Frame
    12 visits in a total of 224 days duratiion from the day of first vaccinantion
    Secondary Outcome Measure Information:
    Title
    Immunogenicity assessment by: A.Detection of IFN gama production after stimulation with Ag85B, ESAT-6 and H1. B.Detection of IgG antibodies to recombinant proteins Ag85B, ESAT-6 and H1 in serum/plasma.
    Time Frame
    12 visits in a total of 224 days duratiion from the day of first vaccinantion

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male between 18 and 40 years old TST negative groups: TST- and negative QuantiFERON-TB Gold In tube test BCG group: known to be BCG-vaccinated > 2 years before(scar, vaccination card), TST+ (> 6 or any documented value > 6 mm on medical file in the past), with no active, chronic or past TB disease as confirmed by chest X ray, negative QuantiFERON-TB Gold In Tube test and negative 6-day lymphocyte tests. Infection group: latent TB, TST+ ( = or > 10 mm or documented = or > 10 mm positive on medical file in the past), previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive QuantiFERON-TB Gold In Tube test and/or positive 6-day lymphocyte test. Healthy based on medical examination/history at the inclusion Signed informed consent Prepared to grant authorized persons access to the medical records The volunteer is likely to comply with instructions Exclusion Criteria: Confirmed active TB based on clinical evaluation(history, physical findings and investigations) Vaccinated with any vaccine 3 months before first vaccination Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) HBV, HCV or HIV sero-positive Participation in other clinical trials Known hypersensitivity to any of the vaccine components Laboratory parameters outside of normal range considered clinically relevant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jemal Hussein, MD
    Organizational Affiliation
    Armauer Hansen Research Institue/AHRI/,Ethiopia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Peter Bang, Msc
    Organizational Affiliation
    Statens serum Institute/SSI/,Denamrk
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29321075
    Citation
    Hussein J, Zewdie M, Yamuah L, Bedru A, Abebe M, Dagnew AF, Chanyalew M, Yohannes AG, Ahmed J, Engers H, Doherty TM, Bang P, Kromann I, Hoff ST, Aseffa A. A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31(R) in people living in a TB-endemic area. Trials. 2018 Jan 10;19(1):24. doi: 10.1186/s13063-017-2354-0.
    Results Reference
    derived

    Learn more about this trial

    A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)

    We'll reach out to this number within 24 hrs