TESEC-07: Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Phase 2/Phase 3 |
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.
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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.
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A group of 150 TB patients will only receive the C-Tb agent randomised to either RIGHT or LEFT forearm.
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A group of 150 TB patients will only receive the reference agent PPD RT 23 randomised to either RIGHT or LEFT forearm.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0.1 µg C-Tb The C-Tb agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme |
Biological: C-Tb
C-Tb is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
|
| Active Comparator: 2 T.U 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 |
Biological: Tuberculin PPD RT 23 SSI
Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
|
| Experimental: 0.1 µg C-Tb / 2 T.U Tuberculin PPD 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 |
Biological: C-Tb / Tuberculin PPD RT 23 SSI
The C-Tb and Tuberculin agents are administered by the Mantoux injection technique to each volunteer in the RIGHT and LEFT forearm according to a double blind randomisation scheme
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria (HIV Negative patients):
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Has signed an informed consent
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Aged 18 to 65 years
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Has been diagnosed with active pulmonary TB:
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has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or
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has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis
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Is HIV negative confirmed by 2 two rapid tests
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Is willing and likely to comply with the trial procedures
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Is prepared to grant authorized persons access to their medical record
Inclusion Criteria (HIV Positive patients):
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Has signed an informed consent
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Aged 18-65 years
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Has been diagnosed with active pulmonary TB:
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has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or
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has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis
- Is HIV positive confirmed by:
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2 positive rapid tests or
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1 positive rapid tests and an additional confirmatory ELISA
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A CD4 count has been performed
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Is willing and likely to comply with the trial procedures
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Is prepared to grant authorized persons access to their medical records
Exclusion Criteria:
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Has been in treatment for TB for more than 2 weeks
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Has a known MDR/XDR-TB
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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
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Has been tuberculin (TST) tested < 12 months prior to the day of inclusion
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Is pregnant, breastfeeding or intending to get pregnant
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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
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Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
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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
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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
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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
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Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens
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Has a condition which in the opinion of the investigator is not suitable for participation in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Be Part Yoluntu Centre | Paarl | Western Cape | South Africa | 7626 |
| 2 | TASK, M2, Karl Bremer Hospital, | Cape Town | South Africa | 7530 | |
| 3 | Tiervlei Trial Centre, Karl Bremer Hospital | Cape Town | South Africa | 7530 | |
| 4 | UCT Lung Institute | Cape Town | South Africa | 7925 | |
| 5 | Primecure Medicentre | Port Elizabeth | South Africa | 6014 | |
| 6 | Synexus Stanza Bopape Clinic | Pretoria | South Africa | 0122 | |
| 7 | Setshaba Research Centre | Pretoria | South Africa | 0152 |
Sponsors and Collaborators
- Statens Serum Institut
Investigators
- Study Director: Pernille N Tingskov, BN, RN, Statens Serum Institut
- Principal Investigator: Keertan Dheda, MD, Prof, UCT Lung Institute, University of Cape Town
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TESEC-07