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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT01003093
First received: October 27, 2009
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Tuberculosis
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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel 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 at 0 and 2 Months

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests. [ Time Frame: From the first vaccination until 8 months after the first vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: From first vaccination until 36 months after first vaccination ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2005
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Antigen H1 + IC31

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003093

Locations
Netherlands
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
  More Information

No publications provided by Statens Serum Institut

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT01003093     History of Changes
Other Study ID Numbers: THYB-01, Eudract number: TEST-001599-14
Study First Received: October 27, 2009
Last Updated: January 18, 2013
Health Authority: The Nederlands: National Institute for Public Health and the Environment (RIVM)
The Netherlands: Comissie Medische Ethiek, Leiden University Medical Centre

Keywords provided by Statens Serum Institut:
Tuberculosis
Vaccine
Ag85B
ESAT-6
IC31

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

ClinicalTrials.gov processed this record on April 21, 2014