A phase IIa specificity trial of the diagnostic agent C-Tb, when given intradermally by the Mantoux technique to healthy volunteers previously vaccinated with BCG - A specificity trial of the diagnostic agent C-Tb

Phase 1

• Conditions: The intended indication for the product is to be a diagnostic tool to detect infection with M.tuberculosis; MedDRA version: 10 Level: LLT Classification code 10044755 Term: tuberculosis

• Registration Number: EUCTR2009-017296-17-GB
• Lead Sponsor: Statens Serum Institut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-22
• Study Completion: 2011-10-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 151

Inclusion Criteria

1.Has signed an informed consent
2.Aged 18 to 65 years
3.Is known to be BCG vaccinated (documented in medical files and/or by the presence of a BCG scar)
4.Is healthy according to a medical examination, medical history and laboratory investigations at inclusion
5.Is willing and likely to comply with the trial procedures
6. Is prepared to grant authorized persons access to their medical records

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Has a history of tuberculosis or has been in close contact to a person with active tuberculosis within 5 years from trial inclusion
2.Has a positive QuantiFERON®-TB Gold In-Tube assay at inclusion
3.Laboratory parameters outside of normal range judged by site investigator to be clinically significant
4.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)
5.Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines)
6.Has been vaccinated with BCG < 6 months prior to the day of inclusion
7.Has been tuberculin (TST) tested < 6 months prior to the day of inclusion
8.Has a known congenital or acquired immune deficiency
9.Has an active disease affecting the lymphoid organs (e.g., Hodgkin’s disease, lymphoma, leukaemia, sarcoidosis)
10.Is infected with HIV
11.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
12.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
13.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
14.Has participated in previous clinical trials investigating the ESAT-6 and/or CPP-10 antigens
15.Is pregnant, breast-feeding or intending to get pregnant
16.Is a female not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures
17.Has a history of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit 1
18.Has a positive urine drug screen at Visit 1 and Visit 2 (i.e., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates)
19.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]
20.Has a condition which in the opinion of the investigator is not suitable for participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified