Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT00793702
First received: November 17, 2008
Last updated: January 18, 2013
Last verified: January 2013

November 17, 2008
January 18, 2013
November 2008
July 2009   (final data collection date for primary outcome measure)
Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection [ Time Frame: onset between the first injection and 28 days after the second injection ] [ Designated as safety issue: Yes ]
Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection. [ Time Frame: onset between the first injection and 28 days after the second injection ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00793702 on ClinicalTrials.gov Archive Site
The diameter of induration at the second injection site measured transversely to the long axis of the forearm [ Time Frame: 72 hours after the second injection ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration
An Open Phase I Clinical Trial on the Safety and Risk of Sensitisation by Escalating Doses and Repeated Injections of the rdESAT-6 + rCFP-10 Skin Test Reagent Following Intradermal Administration to Healthy Adults

The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or 12 weeks to healthy adults.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Tuberculosis
Biological: rdESAT-6 + rCFP-10
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
  • Experimental: A
    two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval)
    Intervention: Biological: rdESAT-6 + rCFP-10
  • Experimental: B
    two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval)
    Intervention: Biological: rdESAT-6 + rCFP-10
  • Experimental: C
    two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval)
    Intervention: Biological: rdESAT-6 + rCFP-10
  • Experimental: D
    two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval)
    Intervention: Biological: rdESAT-6 + rCFP-10
  • Experimental: E
    one injection 1.0 µg rdESAT-6 + rCFP-10
    Intervention: Biological: rdESAT-6 + rCFP-10
Bergstedt W, Tingskov PN, Thierry-Carstensen B, Hoff ST, Aggerbeck H, Thomsen VO, Andersen P, Andersen AB. First-in-man open clinical trial of a combined rdESAT-6 and rCFP-10 tuberculosis specific skin test reagent. PLoS One. 2010 Jun 25;5(6):e11277.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Has signed an informed consent
  2. Is willing and likely to be able to comply with the trial procedures
  3. Is female/male non-black adult ≥ 18 years and ≤ 55 years of age
  4. Is healthy according to a medical examination, medical history and laboratory investigations at inclusion
  5. Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

  1. Has a history of tuberculosis or has had a known contact to a person with active tuberculosis
  2. Has a positive QuantiFERON-TB Gold In Tube test result at inclusion
  3. Laboratory parameters outside of normal range judged by principal investigator to be clinically significant and/or abnormal glucose or protein levels in a urine sample at inclusion
  4. Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine, infliximab or blood products)
  5. Has been vaccinated with a live vaccine within 6 months prior to the day of inclusion (e.g., MMR, yellow fever, or oral typhoid vaccines)
  6. Has a known congenital or acquired immune deficiency
  7. Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukemia, sarcoidosis)
  8. Is known to be infected with HIV, HBV or HCV
  9. Has a severe ongoing viral or bacterial infection that might affect the cell mediated immune response at inclusion
  10. Has a C-reactive protein (CRP) level > 50 mg/L
  11. Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection site(s)
  12. Has a condition in which repeated blood drawings pose more than minimal risk for the volunteer, such as haemophilia, other coagulation disorders, or significantly impaired venous access
  13. Is actively participating in another clinical trial or has participated in previous clinical trials investigating the rdESAT-6 skin test reagent
  14. Is pregnant according to urine pregnancy test at inclusion
  15. Is a female not willing to use contraceptives or is breastfeeding
  16. Has a condition which in the opinion of the investigator is not suitable for participation in the study
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00793702
TESEC-01, EUDRACT No.: 2008-001489-96
Yes
Statens Serum Institut
Statens Serum Institut
Not Provided
Study Director: Pernille Nyholm Tingskov Statens Serum Institut
Statens Serum Institut
January 2013

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