GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients.
GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients. Chronic HCV patients will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed up for safety and immunological response through week 28. All vaccine recipients will take part in a long-term safety follow-up for 6 months following the completion of the vaccine series to assess delayed adverse events. Vaccination will first start at low dose. The investigators will enroll low dose group first. Two subjects will be staggering enrolled every 2 weeks. Following the assessment and review of prior vaccinations, if no vaccine definitely or probably-related severe adverse event (grade 3 or above) or SAE occurs the vaccination schedule for low dose and high dose will continue until complete enrollment. Each subject will receive HCVax™ vaccine at 0, 8, 16 weeks through subcutaneous route. Following vaccination subjects will have clinical, immunological and virologic assessments throughout the 28-week study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
HCVax is a lentiviral vector encoding several HCV antigens
Virginia Commonwealth University, Medical Center
Richmond, Virginia, United States
RECRUITINGTo evaluate the safety of a therapeutic HCV vaccine in chronic HCV patients
Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity signs and symptoms following vaccinations.
Time frame: 40 weeks
To evaluate the immunogenicity of a therapeutic HCV vaccine in chronic HCV patients
Magnitude of IFN-γ \& IL-2 producing CD4+ and CD8+ T cells to HCV core peptides pools at weeks 8, 16, and 24.
Time frame: 40 weeks
Virologic response
Sustained viral response (SVR) will be defined as negative HCV RNA result using an assay that has sensitivity of 25 IU or less per milliliter at 12 weeks after the end of vaccination.
Time frame: 40 weeks
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