In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell responses both systemically and locally in the bladder.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
5 doses every 3 weeks
1 intravesical dose /week for 6 weeks
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
Time frame: 6 months
Flow cytometric analysis of type and number of immune cell types in urine
Time frame: 6 months
Measurement of titers of antibodies against recMAGE-A3 in serum
Time frame: 6 months
Assessment of disease recurrence by control cystoscopy
Time frame: 6 months
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