Status:
COMPLETED
Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration
Lead Sponsor:
Statens Serum Institut
Conditions:
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- Has signed an informed consent
- Is willing and likely to be able to comply with the trial procedures
- Is female/male non-black adult ≥ 18 years and ≤ 55 years of age
- Is healthy according to a medical examination, medical history and laboratory investigations at inclusion
- Is prepared to grant authorized persons access to their medical records
Exclusion
- Has a history of tuberculosis or has had a known contact to a person with active tuberculosis
- Has a positive QuantiFERON-TB Gold In Tube test result at inclusion
- 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
- 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)
- 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)
- Has a known congenital or acquired immune deficiency
- Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukemia, sarcoidosis)
- Is known to be infected with HIV, HBV or HCV
- Has a severe ongoing viral or bacterial infection that might affect the cell mediated immune response at inclusion
- Has a C-reactive protein (CRP) level \> 50 mg/L
- Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection site(s)
- 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
- Is actively participating in another clinical trial or has participated in previous clinical trials investigating the rdESAT-6 skin test reagent
- Is pregnant according to urine pregnancy test at inclusion
- Is a female not willing to use contraceptives or is breastfeeding
- Has a condition which in the opinion of the investigator is not suitable for participation in the study
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00793702
Start Date
November 1 2008
End Date
July 1 2009
Last Update
January 21 2013
Active Locations (1)
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1
Rigshospitalet, Epidemiklinikken
Copenhagen, Denmark, 2100