Status:
COMPLETED
A Trial of the C-Tb Skin Test, When Given Intradermally to Healthy Volunteers Previously Vaccinated With BCG
Lead Sponsor:
Statens Serum Institut
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result wi...
Detailed Description
The trial is designed to investigate the specificity of C-Tb under various definitions of cut-off in a double blind randomised, split-body study comparing 0.1 µg/0.1 mL C-Tb with the reference agent 2...
Eligibility Criteria
Inclusion
- Has signed an informed consent
- Aged 18 to 65 years
- Is known to be BCG vaccinated (documented in medical files and/or by the presence of a BCG scar)
- Is healthy according to a medical examination and medical history at screening
- Is willing and likely to comply with the trial procedures
- Is prepared to grant authorized persons access to their medical records
Exclusion
- Has a history of tuberculosis or has been in close contact to a person with active tuberculosis within 5 years from trial inclusion
- Has a positive QuantiFERON®-TB Gold In-Tube assay at inclusion
- Laboratory parameters outside of normal range judged by site investigator to be clinically significant
- Has within 3 months prior to the day of inclusion been in treatment with a product which is likely to modify the immune response (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine or blood products)
- Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines)
- Has been vaccinated with BCG \< 6 months prior to the day of inclusion
- Has been tuberculin (TST) tested \< 6 months prior to the day of inclusion
- Has a known congenital or acquired immune deficiency
- Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- Is infected with HIV
- Has a current skin condition which interferes with the reading of the skin tests e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
- Has a condition where blood drawings pose more than minimal risk for the volunteer, such as haemophilia, other coagulation disorders, or significantly impaired venous access
- Currently participating in another clinical trial with an investigational or non investigational drug or device, or has participated in another clinical trial within the 3 months prior to dosing
- Has participated in previous clinical trials investigating the ESAT-6 and/or CPP-10 antigens
- Is pregnant, breast-feeding or intending to get pregnant
- Is a female not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures
- Has a history of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit 1
- Has a positive urine drug screen at Visit 1 and Visit 2 (i.e., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates)
- Has a positive alcohol breath test at Visit 1 and Visit 2. \[NOTE: subjects must be told to avoid consumption of alcoholic beverages for at least 24 hours prior to attending the Centre\]
- Has a condition which in the opinion of the investigator is not suitable for participation in the study
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01242475
Start Date
April 1 2011
End Date
November 1 2011
Last Update
January 21 2013
Active Locations (1)
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1
Surrey Clinical Research Centre, University of Surrey
Surrey, Guildford, Surrey, United Kingdom, GU2 7XP