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

NCT00793702 | Completed Phase 1 DMC

• 2 other identifiers: TESEC-01EUDRACT No.: 2008-001489-96
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

tuberculosis; diagnosis; ESAT-6; CFP-10; skin test; Skin test for the diagnosis of tuberculosis infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The diameter of induration at the second injection site measured transversely to the long axis of the forearm

  72 hours after the second injection

Study Arms (5)

A

EXPERIMENTAL

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

Biological: rdESAT-6 + rCFP-10

B

EXPERIMENTAL

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

Biological: rdESAT-6 + rCFP-10

C

EXPERIMENTAL

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

Biological: rdESAT-6 + rCFP-10

D

EXPERIMENTAL

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

Biological: rdESAT-6 + rCFP-10

E

EXPERIMENTAL

one injection 1.0 µg rdESAT-6 + rCFP-10

Biological: rdESAT-6 + rCFP-10

Interventions

rdESAT-6 + rCFP-10 BIOLOGICAL

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

A; B; C; D; E

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 prepared to grant authorized persons access to their medical records

You may not qualify if:

• Has a history of tuberculosis or has had a known contact to a person with active tuberculosis
• Has a known congenital or acquired immune deficiency
• Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukemia, sarcoidosis)
• Is known to be infected with HIV, HBV or HCV
• 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 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

Sponsors & Collaborators

• Statens Serum Institut: lead

Study Sites (1)

Rigshospitalet, Epidemiklinikken

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 20593018 DERIVED

MeSH Terms

Conditions

Tuberculosis; Disease

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pernille Nyholm Tingskov

  Statens Serum Institut

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

DK (1)