Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses
- Conditions
- Tuberculosis
- Interventions
- Biological: C-TbBiological: Tuberculin PPD RT 23 SSIBiological: C-Tb / Tuberculin PPD RT 23 SSI
- Registration Number
- NCT01779102
- Lead Sponsor
- Statens Serum Institut
- 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 induration at the injection site, while a negative test will leave no reactions.
The aim of this study is to address if the size of induration and the sensitivity of C-Tb is influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.
- Detailed Description
The TESEC-07 trial is a GCP double blind randomised controlled phase II/III trial investigating if concomitant injections of the diagnostic agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI affect the induration responses in combination with a safety assessment of C-Tb. TESEC-07 is a multi-centre trial and will be conducted in South Africa in patients recently diagnosed with TB comprising 360 HIV negative and 90 HIV positive adults allocated to 3 trial groups.
* A within group paired comparison of 0.1 μg/0.1 mL C-Tb and PPD RT 23 in 150 TB patients. The C-Tb and PPD RT 23 agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a randomisation scheme.
* A group of 150 TB patients will only receive the C-Tb agent randomised to either RIGHT or LEFT forearm.
* A group of 150 TB patients will only receive the reference agent PPD RT 23 randomised to either RIGHT or LEFT forearm.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 456
Not provided
- Has been in treatment for TB for more than 2 weeks
- Has a known MDR/XDR-TB
- Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) except BCG vaccine
- Has been tuberculin (TST) tested < 12 months prior to the day of inclusion
- Is pregnant, breastfeeding or intending to get pregnant
- Is a female of child bearing potential not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period
- Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- 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 patient, 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 CFP-10 antigens
- Has a condition which in the opinion of the investigator is not suitable for participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.1 µg C-Tb C-Tb The C-Tb agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme 2 T.U Tuberculin PPD RT 23 SSI Tuberculin PPD RT 23 SSI The 2 T.U Tuberculin PPD RT 23 SSI agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme 0.1 µg C-Tb / 2 T.U Tuberculin PPD C-Tb / Tuberculin PPD RT 23 SSI The C-Tb and 2 T.U Tuberculin PPD RT 23 SSI agents are given concomitantly to volunteers in the RIGHT and LEFT forearms according to a double blind randomisation scheme
- Primary Outcome Measures
Name Time Method To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives) Onset from the injection(s) to 28 days after the injections To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients Onset from the injection(s) to 28 days after the injections
- Secondary Outcome Measures
Name Time Method To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the in vitro QuantiFERON®TB Gold In Tube assay in blood collected immediately before application of the C-Tb skin test Onset from the injection(s) to 28 days after the injections To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the PPD RT 23 test Onset from the injection(s) to 28 days after the injections To assess the safety of C-Tb skin test by investigating laboratory safety parameters and assessing all adverse events (local and systemic) occurring within 28 days after administration of the C-Tb and/or PPD RT 23 tests Onset from the injection(s) to 28 days after the injections
Trial Locations
- Locations (7)
TASK, M2, Karl Bremer Hospital,
🇿🇦Cape Town, South Africa
Be Part Yoluntu Centre
🇿🇦Paarl, Western Cape, South Africa
Tiervlei Trial Centre, Karl Bremer Hospital
🇿🇦Cape Town, South Africa
UCT Lung Institute
🇿🇦Cape Town, South Africa
Primecure Medicentre
🇿🇦Port Elizabeth, South Africa
Synexus Stanza Bopape Clinic
🇿🇦Pretoria, South Africa
Setshaba Research Centre
🇿🇦Pretoria, South Africa