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

June 26, 2009
January 18, 2013
September 2007
June 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00929396 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Tuberculosis
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: 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.
    Intervention: Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
  • 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
    Intervention: Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, Bang P, Tingskov PN, Lingnau K, Nouta J, Hoff ST, Rosenkrands I, Kromann I, Ottenhoff TH, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31® promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine. 2011 Mar 3;29(11):2100-9. doi: 10.1016/j.vaccine.2010.12.135. Epub 2011 Jan 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00929396
THYB-02
Yes
Statens Serum Institut
Statens Serum Institut
Not Provided
Principal Investigator: Jaap van Dissel, MD, Prof. Leiden University Medical Centre
Statens Serum Institut
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP