Tuberculosis Clinical Trial
— TESEC-03Official title:
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 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 will show as redness and/or swelling at the injection site, while a
negative test will leave no reactions.
The aim of this study is to test the C-Tb skin test in healthy adults previously BCG
vaccinated to determine if healthy non tuberculosis infected individuals has a truly
negative test result (this is called determining the specificity of the skin test). To be
able to compare the new skin test with the current Tuberculin skin test volunteers will be
injected with both the C-Tb and the TST skin test.
Status | Completed |
Enrollment | 151 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 and medical history at screening 5. Is willing and likely to comply with the trial procedures 6. Is prepared to grant authorized persons access to their medical records 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United Kingdom | Surrey Clinical Research Centre, University of Surrey | Surrey | Guildford, Surrey |
Lead Sponsor | Collaborator |
---|---|
Statens Serum Institut |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The diameter of induration at the injection sites measured transversely to the long axis of the forearm 2-3 days after application of the agents | From injections to 2-3 days after application of the agents | No | |
Secondary | Injection site adverse reactions within 28 days after application of the agents | Onset between the injections and 28 days after the injections | Yes | |
Secondary | All adverse events occurring within 28 days after application of the agents | Onset between the injections and 28 days after the injections | Yes | |
Secondary | Laboratory safety parameters of haematology and biochemistry | Onset between the injections and 28 days after the injections | Yes | |
Secondary | In vitro IFN-? response as measured by the QuantiFERON®-TB Gold In-Tube assay from blood samples taken at screening and 28 days after the injections of the skin test agents | Onset between the injections and 28 days after the injections | No |
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