Evaluation of the safety and ability to induce an immune response of RUTI vaccine for patients that have completed the first 12 or 16 weeks of standard therapy for drug-resistant tuberculosis

Phase 1

• Conditions: The medical condition to be investigated is culture-confirmed Multidrug-resistant tuberculosis, i.e. tuberculosis resistant to the two first-line drugs Rifampicin and Isoniazid; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000850-36-NL
• Lead Sponsor: Archivel Farma S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-25
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Female or Male patients (aged > 18)
- diagnosed with active MDR-TB
- having successfully completed 16 (Cohort A) or 12 weeks (Cohort B) of MDR-TB treatment fully supervised with beneficial initial response to therapy, evidenced by
i) Clinical response criteria (reduction of weight loss, chronic cough, fever, or night sweats) and
ii) Microbiological response criteria (improvement in at least two measurements at least 4 weeks apart using Mycobacterial Growth Indicator Tube (MGIT, also known as liquid culture)), and
iii) Radiological response criteria (Chest X-Ray)

- The patient must provide written informed consent
- The patient must be willing and able to attend all study visits and comply with all study procedures
- Females of childbearing potential must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control during and 30 days after the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Inability to provide written informed consent
•Women reported, or detected, or willing to be pregnant during the trial period;
•Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4; Central Nervous System involvement of TB (TB meningitis, intra-cranial tuberculomas) as there is too little evidence for effective drug penetration for second-line TB drugs;
•Major co-morbid conditions precluding full evaluation, i.e., active lung cancer, acute coronary syndrome, heart failure exceeding NYHA class 2; a diagnosis of metastasized malignancy; renal failure in excess of creatinine clearance < 30 mls/min calculated by the Cockcroft-Gault formula, which would severely complicate administration of aminoglycosides and capreomycin, considered as the major second-line TB drugs; obesity (BMI>30 kg/m2); chronic liver disease – Child-Pugh class C;
•Any of the following laboratory parameters:
oAspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)
ototal bilirubine > 2 x ULN
oNeutrophil count = 500 neutrophils / mm3
oPlatelet count < 50,000 cells / mm3
•Receiving or anticipated to receive a daily dose of = 10 mg of systemic prednisone or equivalent within the period starting 14 days prior to enrolment. Note: patients are allowed to receive an acute, short course of methylprednisolone or prednisone or equivalent for management of an acute exacerbation of COPD or reactive airway disease in asthmatics
•Cytotoxic chemotherapy or radiation therapy within the previous 3 months
•HIV co-infection, if CD4 count < 350 copies/mL; those with 350 copies/mL are expected to be able to mount a sufficient cellular immune response and will therefore be eligible
•Blood transfusion in the last three weeks prior to the trial
•Documented allergy to TB vaccines, notably, to the RUTI® vaccine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified