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

Phase 1

Completed

• Conditions: Tuberculosis
• Interventions: Biological: rdESAT-6 + rCFP-10

• Registration Number: NCT00793702
• Lead Sponsor: Statens Serum Institut

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-19
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	rdESAT-6 + rCFP-10	two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval)
B	rdESAT-6 + rCFP-10	two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval)
C	rdESAT-6 + rCFP-10	two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval)
D	rdESAT-6 + rCFP-10	two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval)
E	rdESAT-6 + rCFP-10	one injection 1.0 µg rdESAT-6 + rCFP-10

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The diameter of induration at the second injection site measured transversely to the long axis of the forearm	72 hours after the second injection

Trial Locations

Locations (1)

Rigshospitalet, Epidemiklinikken; 🇩🇰 Copenhagen, Denmark