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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01242475
• Date of registration: 16/11/2010
• Prospective Registration: Yes
• Primary sponsor: Statens Serum Institut
• Public title: A Trial of the C-Tb Skin Test, When Given Intradermally to Healthy Volunteers Previously Vaccinated With BCG TESEC-03
• Scientific title: A Phase IIa Specificity Trial of the Diagnostic Agent C-Tb, When Given Intradermally by the Mantoux Technique to Healthy Volunteers Previously Vaccinated With BCG
• Date of first enrolment: April 2011
• Target sample size: 151
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01242475
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: David JM Lewis, MD
• Affiliation: Surrey Clinical Research Centre, University of Surrey

• Name: Birgit Thierry-Carstensen
• Affiliation: Statens Serum Institut

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Has signed an informed consent

2. Aged 18 to 65 years

3. Is known to be BCG vaccinated (documented in medical files and/or by the presence of
a BCG scar)

4. Is healthy according to a medical examination and medical history at screening

5. Is willing and likely to comply with the trial procedures

6. Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

1. Has a history of tuberculosis or has been in close contact to a person with active
tuberculosis within 5 years from trial inclusion

2. Has a positive QuantiFERON®-TB Gold In-Tube assay at inclusion

3. Laboratory parameters outside of normal range judged by site investigator to be
clinically significant

4. Has within 3 months prior to the day of inclusion been in treatment with a product
which is likely to modify the immune response (e.g., immunoglobulin, systemic
corticosteroids, methotrexate, azathioprine, cyclosporine or blood products)

5. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion
(e.g. MMR, yellow fever, oral typhoid vaccines)

6. Has been vaccinated with BCG < 6 months prior to the day of inclusion

7. Has been tuberculin (TST) tested < 6 months prior to the day of inclusion

8. Has a known congenital or acquired immune deficiency

9. Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease,
lymphoma, leukaemia, sarcoidosis)

10. Is infected with HIV

11. 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

12. 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

13. 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

14. Has participated in previous clinical trials investigating the ESAT-6 and/or CPP-10
antigens

15. Is pregnant, breast-feeding or intending to get pregnant

16. Is a female not willing to use effective barrier (including spermicidal gel),
hormonal or intrauterine contraceptive measures

17. Has a history of alcohol, narcotic, benzodiazepine, or other substance abuse or
dependence within the 12 months preceding Visit 1

18. Has a positive urine drug screen at Visit 1 and Visit 2 (i.e., amphetamines,
barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates)

19. 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]

20. Has a condition which in the opinion of the investigator is not suitable for
participation in the study



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: C-Tb

Biological: 2 TU Tuberculin PPD RT 23 SSI

Primary Outcome(s)

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 [Time Frame: From injections to 2-3 days after application of the agents]

Secondary Outcome(s)

All adverse events occurring within 28 days after application of the agents [Time Frame: Onset between the injections and 28 days after the injections]

In vitro IFN-? 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 [Time Frame: Onset between the injections and 28 days after the injections]

Laboratory safety parameters of haematology and biochemistry [Time Frame: Onset between the injections and 28 days after the injections]

Injection site adverse reactions within 28 days after application of the agents [Time Frame: Onset between the injections and 28 days after the injections]

Secondary ID(s)

2009-017296-17

TESEC-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors