A Trial of the C-Tb Skin Test, When Given Intradermally to Healthy Volunteers Previously Vaccinated With BCG

NCT01242475 | Completed Phase 2

• 2 other identifiers: TESEC-032009-017296-17
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or swelling at the injection site, while a negative test will leave no reactions. The aim of this study is to test the C-Tb skin test in healthy adults previously BCG vaccinated to determine if healthy non tuberculosis infected individuals has a truly negative test result (this is called determining the specificity of the skin test). To be able to compare the new skin test with the current Tuberculin skin test volunteers will be injected with both the C-Tb and the TST skin test.

Conditions

Tuberculosis

Keywords

tuberculosis; rdESAT-6; CFP-10; skin test; diagnostic test

Outcome Measures

Primary Outcomes (1)

• The diameter of induration at the injection sites measured transversely to the long axis of the forearm 2-3 days after application of the agents

  From injections to 2-3 days after application of the agents

Secondary Outcomes (4)

• Injection site adverse reactions within 28 days after application of the agents

  Onset between the injections and 28 days after the injections

• All adverse events occurring within 28 days after application of the agents

  Onset between the injections and 28 days after the injections

• Laboratory safety parameters of haematology and biochemistry

  Onset between the injections and 28 days after the injections

• In vitro IFN-γ response as measured by the QuantiFERON®-TB Gold In-Tube assay from blood samples taken at screening and 28 days after the injections of the skin test agents

  Onset between the injections and 28 days after the injections

Study Arms (2)

0.1µg/0.1 mL C-Tb

EXPERIMENTAL

The C-Tb and 2 TU Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a double blind randomisation scheme

Biological: C-Tb

2TU Tuberculin PPD RT 23 SSI

ACTIVE COMPARATOR

The C-Tb and 2 TU Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a double blind randomisation scheme

Biological: 2 TU Tuberculin PPD RT 23 SSI

Interventions

C-Tb BIOLOGICAL

The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme

Also known as: rdESAT-6 + rCFP-10

0.1µg/0.1 mL C-Tb

2 TU Tuberculin PPD RT 23 SSI BIOLOGICAL

The 2TU Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme

Also known as: PPD, Tuberculin

2TU Tuberculin PPD RT 23 SSI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has signed an informed consent
• Aged 18 to 65 years
• Is known to be BCG vaccinated (documented in medical files and/or by the presence of a BCG scar)
• Is healthy according to a medical examination and medical history at screening
• Is willing and likely to comply with the trial procedures
• Is prepared to grant authorized persons access to their medical records

You may not qualify if:

• Laboratory parameters outside of normal range judged by site investigator to be clinically significant
• Has a known congenital or acquired immune deficiency
• Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
• Is infected with HIV
• Has a current skin condition which interferes with the reading of the skin tests e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
• Has a condition where blood drawings pose more than minimal risk for the volunteer, such as haemophilia, other coagulation disorders, or significantly impaired venous access
• Currently participating in another clinical trial with an investigational or non investigational drug or device, or has participated in another clinical trial within the 3 months prior to dosing
• Has participated in previous clinical trials investigating the ESAT-6 and/or CPP-10 antigens
• Is pregnant, breast-feeding or intending to get pregnant
• Is a female not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures
• Has a history of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit 1
• Has a positive urine drug screen at Visit 1 and Visit 2 (i.e., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates)
• Has a positive alcohol breath test at Visit 1 and Visit 2. \[NOTE: subjects must be told to avoid consumption of alcoholic beverages for at least 24 hours prior to attending the Centre\]
• 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)

Surrey Clinical Research Centre, University of Surrey

Surrey, Guildford, Surrey, GU2 7XP, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Tuberculin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• Birgit Thierry-Carstensen

  Statens Serum Institut

  STUDY DIRECTOR

• David JM Lewis, MD

  Surrey Clinical Research Centre, University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Study Start: April 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

GB (1)