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
  Purpose

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.


Condition Intervention Phase
Tuberculosis
Biological: rdESAT-6 + rCFP-10
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: November 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval)
Biological: rdESAT-6 + rCFP-10
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
Experimental: B
two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval)
Biological: rdESAT-6 + rCFP-10
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
Experimental: C
two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval)
Biological: rdESAT-6 + rCFP-10
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
Experimental: D
two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval)
Biological: rdESAT-6 + rCFP-10
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
Experimental: E
one injection 1.0 µg rdESAT-6 + rCFP-10
Biological: rdESAT-6 + rCFP-10
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique

  Eligibility

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

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
  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: NCT00793702

Locations
Denmark
Rigshospitalet, Epidemiklinikken
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Statens Serum Institut
Investigators
Study Director: Pernille Nyholm Tingskov Statens Serum Institut
  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: NCT00793702     History of Changes
Other Study ID Numbers: TESEC-01, EUDRACT No.: 2008-001489-96
Study First Received: November 17, 2008
Last Updated: January 18, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Statens Serum Institut:
tuberculosis
diagnosis
ESAT-6
CFP-10
skin test
Skin test for the diagnosis of tuberculosis infection

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

ClinicalTrials.gov processed this record on September 18, 2014