Tuberculosis
Conditions
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.
Interventions
BIOLOGICALC-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
BIOLOGICALTuberculin 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
BIOLOGICALC-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
Sponsors
Statens Serum Institut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
(HIV Negative patients): * Has signed an informed consent * Aged 18 to 65 years * Has been diagnosed with active pulmonary TB: 1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or 2. 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 negative confirmed by 2 two rapid tests * Is willing and likely to comply with the trial procedures * Is prepared to grant authorized persons access to their medical record Inclusion Criteria (HIV Positive patients): * Has signed an informed consent * Aged 18-65 years * Has been diagnosed with active pulmonary TB: 1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or 2. 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: 1. 2 positive rapid tests or 2. 1 positive rapid tests and an additional confirmatory ELISA * A CD4 count has been performed * Is willing and likely to comply with the trial procedures * Is prepared to grant authorized persons access to their medical records
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Africa
Outcome results
None listed