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

Sponsored by:	Statens Serum Institut
Information provided by:	Statens Serum Institut
ClinicalTrials.gov Identifier:	NCT00793702

Purpose

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 to 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.

Condition	Intervention	Phase
Tuberculosis	Biological: rdESAT-6 + rCFP-10	Phase I

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
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

Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:

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. [ Time Frame: onset between the first injection and 28 days after the second injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The diameter of induration at the second injection site measured transversely to the long axis of the forearm [ Time Frame: 72 hours after the second injection ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval)	Biological: rdESAT-6 + rCFP-10 rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
B: Experimental two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval)	Biological: rdESAT-6 + rCFP-10 rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
C: Experimental two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval)	Biological: rdESAT-6 + rCFP-10 rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
D: Experimental two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval)	Biological: rdESAT-6 + rCFP-10 rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
E: Experimental one injection 1.0 µg rdESAT-6 + rCFP-10	Biological: rdESAT-6 + rCFP-10 rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Has signed an informed consent
Is willing and likely to be able to comply with the trial procedures
Is female/male non-black adult ≥ 18 years and ≤ 55 years of age
Is healthy according to a medical examination, medical history and laboratory investigations at inclusion
Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

Has a history of tuberculosis or has had a known contact to a person with active tuberculosis
Has a positive QuantiFERON-TB Gold In Tube test result at inclusion
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
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)
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)
Has a known congenital or acquired immune deficiency
Has a disease affecting the lymphoid organs (e.g Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
Is known to be infected with HIV, HBV or HCV
Has a severe ongoing viral or bacterial infection that might affect the cell mediated immune response at inclusion
Has a C-reactive protein (CRP) level > 50 mg/L
Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection site(s)
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
Is actively participating in another clinical trial or has participated in previous clinical trials investigating the rdESAT-6 skin test reagent
Is pregnant according to urine pregnancy test at inclusion
Is a female not willing to use contraceptives or is breastfeeding
Has a condition which in the opinion of the investigator is not suitable for participation in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793702

Contacts

Contact: Åse Bengård Andersen, MD

+45 35 45 85 55

bengaard@rh.dk

Locations

Denmark
Epidemiklinikken, Rigshospitalet
Copenhagen Ø, Denmark, 2100

Sponsors and Collaborators

Statens Serum Institut

Investigators

Study Director:

Pernille Nyholm Tingskov

Statens Serum Institut

More Information

Responsible Party:	Statens Serum Institut, Division of Vaccine, Vaccine Development Department ( Ingrid Kroman )
Study ID Numbers:	TESEC-01, EUDRACT No.: 2008-001489-96
Study First Received:	November 17, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00793702
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Statens Serum Institut:

tuberculosis
diagnosis
ESAT-6

CFP-10
skin test
Skin test for the diagnosis of tuberculosis infection

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis
Healthy

Additional relevant MeSH terms:

Actinomycetales Infections

ClinicalTrials.gov processed this record on January 15, 2009