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A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers (THYB-02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT00929396
First received: June 26, 2009
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.


Condition Intervention Phase
Tuberculosis
 Biological: 50 microg. antigen + adjuvant (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 in PPD Positive Volunteers at 0 and 2 Months

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

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 first vaccination until 8 months after the first vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Detection by ELISPOT of IFNgamma spot-forming cells in PBMCs. Detection by ELISA of IFNgamma production in supernatants of PBMC. Detection by ELISA of IgG antibodies in serum/plasma. Detection by Elisa of TNFalfa and IFNgamma in serum [ Time Frame: From first vaccination until 8 months after first vaccination ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Latent TB infection group
The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart.
 Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
o,5 mL suspension for injection x 2 with 2 months interval
Other Name: Antigen H1 + adjuvant IC31
Experimental: BCG vaccinated group
The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart
 Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
o,5 mL suspension for injection x 2 with 2 months interval
Other Name: Antigen H1 + adjuvant IC31

  Eligibility

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

Inclusion Criteria:

  • Male and female between 18 and 55 years old
  • BCG group: Known to be BCG-vaccinated over 2 years before, PPD positive (range 6-15 mm or any documented value between 6-15 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: Known to be treated for latent TB, PPDpositive (equal or over 10 mm or documented equal or over 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:

  • Granulomatous disease (by chest X-ray)
  • 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
  • Participation in other clinical trials
  • Known hypersensitivity to any of the vaccine components
  • Laboratory parameters outside of normal range judged by PI to be clinically relevant
  • Pregnant women/planned pregnancy and/or breastfeeding within the trial period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929396

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: NCT00929396     History of Changes
Other Study ID Numbers: THYB-02
Study First Received: June 26, 2009
Last Updated: January 18, 2013
Health Authority: Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013