E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The intended indication for the product is to be a diagnostic tool to detect infection with M.tuberculosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 10 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10044755 |
E.1.2 | Term | tuberculosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the specificity of the C-Tb skin test as a function of the cut-off value (i.e., the smallest size of induration measured in mm resulting in a negative outcome of the C-Tb test) when the test is administered intradermally by the Mantoux technique to healthy BCG vaccinated adults.
The present phase IIa (TESEC-03) trial in a healthy BCG vaccinated population will collect data on the distribution of the induration response, if any, to C-Tb in this population. The specificity of the C-Tb test will be defined as the relative frequency of subjects in a healthy population (i.e., no exposure to MTb) who have an induration response < cut-off after a C-Tb test.
A parallel phase IIb trial (TESEC-04) is planned in patients recently diagnosed with TB +/- HIV to collect data on the distribution of the induration response to C-Tb in these populations. Similarly the sensitivity is defined as the relative frequency of patients with an induration response ≥ cut-off in TB patients. The pha |
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E.2.2 | Secondary objectives of the trial |
-To compare the induration response of C-Tb with the induration response of 2 T.U. Tuberculin PPD RT 23 SSI -To compare the induration response of C-Tb with the in-vitro IFN-gamma response measured at screening and 28 days after the injections of the skin test agents using the QuantiFERON®-TB Gold In-Tube assay -To record all adverse events occurring within 28 days after application of the agents
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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, medical history and laboratory investigations at inclusion 5.Is willing and likely to comply with the trial procedures 6. Is prepared to grant authorized persons access to their medical records
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be 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 C-Tb and 2 T.U. Tuberculin. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
specificity of the skin test agent C-Tb |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
split-body study comparing 0.1 µg/0.1 mL C-Tb with the reference agent 2 T.U. Tuberculin PPD RT23 SS |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last volunteer’s last visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |