Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration

Statens Serum Institut

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Biological: rdESAT-6 + rCFP-10

Study type: Interventional

Funder types: Other

Identifiers

NCT00793702

EUDRACT No.: 2008-001489-96

TESEC-01

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 5 patient groups

A

Experimental group

Description:

two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval)

Treatment:

Biological: rdESAT-6 + rCFP-10

B

Experimental group

Description:

two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval)

Treatment:

Biological: rdESAT-6 + rCFP-10

C

Experimental group

Description:

two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval)

Treatment:

Biological: rdESAT-6 + rCFP-10

D

Experimental group

Description:

two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval)

Treatment:

Biological: rdESAT-6 + rCFP-10

E

Experimental group

Description:

one injection 1.0 µg rdESAT-6 + rCFP-10

Treatment:

Biological: rdESAT-6 + rCFP-10