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

Tuberculosis Clinical Trial

Official title:

An Open Phase I Clinical Trial on the Safety and Risk of Sensitisation by Escalating Doses and Repeated Injections of the rdESAT-6 + rCFP-10 Skin Test Reagent Following Intradermal Administration to Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793702
• Other study ID #: TESEC-01
• Secondary ID: EUDRACT No.: 200
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2008
• Last updated: January 18, 2013
• Start date: November 2008
• Est. completion date: July 2009

Study information

• Verified date: January 2013
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• rdESAT-6 + rCFP-10
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Epidemiklinikken	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The diameter of induration at the second injection site measured transversely to the long axis of the forearm		72 hours after the second injection	No