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

NCT ID: NCT00793702

Last Updated: 2013-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-07-31

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.

Conditions

Tuberculosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

rdESAT-6 + rCFP-10

Intervention Type: BIOLOGICAL

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

B

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

Group Type: EXPERIMENTAL

rdESAT-6 + rCFP-10

Intervention Type: BIOLOGICAL

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

C

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

Group Type: EXPERIMENTAL

rdESAT-6 + rCFP-10

Intervention Type: BIOLOGICAL

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

D

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

Group Type: EXPERIMENTAL

rdESAT-6 + rCFP-10

Intervention Type: BIOLOGICAL

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

E

one injection 1.0 µg rdESAT-6 + rCFP-10

Group Type: EXPERIMENTAL

rdESAT-6 + rCFP-10

Intervention Type: BIOLOGICAL

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

Interventions

rdESAT-6 + rCFP-10

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Statens Serum Institut

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pernille Nyholm Tingskov

Role: STUDY_DIRECTOR

Statens Serum Institut

Locations

Rigshospitalet, Epidemiklinikken

Copenhagen, , Denmark

Countries

Denmark

References

Bergstedt W, Tingskov PN, Thierry-Carstensen B, Hoff ST, Aggerbeck H, Thomsen VO, Andersen P, Andersen AB. First-in-man open clinical trial of a combined rdESAT-6 and rCFP-10 tuberculosis specific skin test reagent. PLoS One. 2010 Jun 25;5(6):e11277. doi: 10.1371/journal.pone.0011277.

Reference Type: DERIVED

PMID: 20593018 (View on PubMed)

Other Identifiers

EUDRACT No.: 2008-001489-96

Identifier Type: -

Identifier Source: secondary_id

TESEC-01

Identifier Type: -

Identifier Source: org_study_id