This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
injection
Unnamed facility
Kantou, Japan
Unnamed facility
Kyushu, Japan
Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests
Time frame: for 365 days after HCT
Local reactogenicity
protocol-specified reactogenicity scale
Time frame: for 14 days following each injection
Incidence of CMV viremia
CMV plasma viral load ≥ 1000 copies
Time frame: for 365 days after HCT
CMV-specified antiviral therapy
CMV-specific AVT(Anti-virus therapy) initiated for a CMV plasma viral load ≥ 1000 copies
Time frame: for 365 days after HCT
Incidence of cytomegalovirus end-organ disease (CMV EOD)
CMV pneumonia, CMV gastroenteritis, CMV hepatitis, et al
Time frame: for 365 days after HCT
Maximum grade of Graft Versus Host Disease (GVHD)
Time frame: for 365 days after HCT
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