Tuberculosis
Conditions
Keywords
tuberculosis, diagnosis, ESAT-6, CFP-10, skin test, Skin test for the diagnosis of tuberculosis infection
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 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.
Interventions
BIOLOGICALrdESAT-6 + rCFP-10
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
Sponsors
Statens Serum Institut
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | onset between the first injection and 28 days after the second injection |
Secondary
| Measure | Time frame |
|---|---|
| The diameter of induration at the second injection site measured transversely to the long axis of the forearm | 72 hours after the second injection |
Countries
Denmark
Outcome results
None listed