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
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: 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
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on October 22, 2014