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THYB-01: A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

Sponsor
Statens Serum Institut (Other)
Overall Status
Completed
CT.gov ID
NCT01003093
Collaborator
(none)
36
Enrollment
1
Location
3
Arms
31
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

Condition or Disease Intervention/Treatment Phase
  • Biological: 50 microgram antigen (Ag85B + ESAT-6)
  • Biological: 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a
  • Biological: 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months
Study Start Date :
Nov 1, 2005
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antigen group + high adjuvans

The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.

Biological: 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
0.5 mL suspension for injection x 2 with 2 months interval
Other Names:
  • Antigen H1 + IC31

    		•
    Experimental: Antigen group

    The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.

    Biological: 50 microgram antigen (Ag85B + ESAT-6)
    0.5 mL suspension for injection x 2 with 2 months interval
    Other Names:
  • Antigen H1

    		•
    Experimental: Antigen + low adjuvans group

    The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart.

    Biological: 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a
    0.5 mL suspension for injection x 2 with 2 months interval
    Other Names:
  • Antigen H1 + IC31

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests. [From the first vaccination until 8 months after the first vaccination]

    Secondary Outcome Measures

    1. Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA. [From first vaccination until 36 months after first vaccination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Male

    • Healthy based on medical examination/history at the inclusion

    • Age between 18 and 55 years

    • Signed informed consent

    • Prepared to grant authorized persons access to the medical records

    • The volunteer is likely to comply with instructions

    Exclusion Criteria:

    • Known exposure to TB before (or expected during) the trial

    • Prior BCG vaccination

    • Granulomatous disease (by chest X-ray, autoimmune screen)

    • Vaccinated with live vaccine 3 months before first vaccination

    • Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination

    • HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)

    • Participation in other clinical trials

    • Positive Mantoux or QuantiFERON-TB Gold

    • Known hypersensitivity to any of the vaccine components

    • Laboratory parameters outside of normal ranges considered clinically relevant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leiden University Medical Centre Leiden RC Leiden Netherlands 2300

    Sponsors and Collaborators

    • Statens Serum Institut

    Investigators

    • Principal Investigator: Jaap van Dissel, MD, Prof., Leiden University Medical Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Statens Serum Institut
    ClinicalTrials.gov Identifier:
    NCT01003093
    Other Study ID Numbers:
    • THYB-01
    • Eudract number: TEST-001599-14
    First Posted:
    Oct 28, 2009
    Last Update Posted:
    Jan 21, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Statens Serum Institut
    Tuberculosis
    Vaccine
    Ag85B
    ESAT-6
    IC31
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of Jan 21, 2013