Class II Invariant Chain HCV Vaccine Study

Exclusion Criteria

• •Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned used during the study period
• •Prior receipt of a recombinant simian adenoviral vaccine
• •Receipt of any investigational HCV vaccine within the last 6 years
• •Administration of immunoglobulins and/or any blood products within the last three months preceding the planned administration of the vaccine candidate
• •Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with the IMP
• •Receipt of other vaccine, including influenza vaccine, within the previous 14 days or planned receipt within 14 days after vaccination with the IMP
• •Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressive medication within the last 6 months (inhaled and topical steroids are allowed)
• •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
• •Any history of anaphylaxis in reaction to vaccination
• •Pregnancy, lactation or willingness/intention to become pregnant during the study
• •Personal history of autoimmune disease
• •History of major autoimmune disease in first degree relative, e.g. Type 1 diabetes, Graves' Disease, Systemic Lupus Erythematosus (SLE) or Spondyloarthropathy (AS).
• •HLA type B27 positive individuals
• •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• •History of serious psychiatric condition
• •Any other serious chronic illness requiring hospital specialist supervision
• •Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• •Suspected or known current injecting drug use
• •Seropositive for hepatitis B surface antigen (HBsAg)
• •Any clinically significant acute or chronic medical condition that is considered unstable/progressive, or in the opinion of the Chief Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study
• •Any clinically significant abnormal finding on screening biochemistry or haematology blood test or urinalysis
• •Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol
• •Vulnerable subjects (according to ICH GCP)
• •Specific for groups 1 and 2:
• •Previous HCV infection
• •Reported current or previous high-risk behaviour for HCV infection (including IVDU)
• •Seropositive for hepatitis C virus (antibodies to HCV) at screening
• •Specific for group 3:
• •HCV RNA positive following DAA treatment
• •Cirrhosis or severe fibrosis (Ishak 5 or 6) as previously defined by any of the following:
• •* Radiological findings on CT, MR or USS
• •* Abnormal biochemical parameters (PT, albumin and bilirubin)
• •* clinical signs of liver decompensation (ascites, varices, encephalopathy)
• •* Ishak score 5 on liver biopsy
• •* Fibroscan at any time point in the past \>12.5kPa