safety study investigating if concomitant injections of c-tb and 2 t.u tuberculin affect induration responses

Conditions: Tuberculosis

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.

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.

Eligibility criteria:
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