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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT01049282
First received: January 13, 2010
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Tuberculosis
Biological: Antigen (Ag85B-ESAT-6)
Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 in Different Antigen/Adjuvant Formulations in TST Negative and TST Positive Volunteers at 0 and 2 Months

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 12 visits in a total of 224 days duratiion from the day of first vaccinantion ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 TST negative volunteers antigen only Biological: Antigen (Ag85B-ESAT-6)
Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Experimental: 12 TST negative volunteers Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Experimental: 12 BCG vaccinated volunteers Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Experimental: 12 with Latent TB infection >= 2 years ago Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval

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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049282

Sponsors and Collaborators
Statens Serum Institut
Investigators
Principal Investigator: Jemal Hussein, MD Armauer Hansen Research Institue/AHRI/,Ethiopia
Study Director: Peter Bang, Msc Statens serum Institute/SSI/,Denamrk
  More Information

No publications provided

Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT01049282     History of Changes
Other Study ID Numbers: THYB-03
Study First Received: January 13, 2010
Last Updated: January 18, 2013
Health Authority: Ethiopia: Ethical Review Committee
Ethiopia: Drug Administration and Control Authority

Keywords provided by Statens Serum Institut:
safety
immunogenicity
adjuvanted TB subunit vaccine

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on November 24, 2014