A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive Individuals

Exclusion Criteria

• •* Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
• •* Prior receipt of a recombinant simian or human adenoviral vaccine
• •* Clinical, biochemical (abnormal liver synthetic dysfunction defined by an elevated blood prothrombin time or a low blood albumin level), ultrasonographic, FibroscanTM, or liver biopsy (histology) evidence of cirrhosis or portal hypertension
• •* Ongoing or recent (\<12 months) AIDS defining illness (US Centers for Disease Control and Prevention (CDC) definition)
• •* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including egg products or gentamicin.
• •* History of clinically significant contact dermatitis
• •* Any history of anaphylaxis or serious reaction in relation to vaccination
• •* Pregnancy, lactation or willingness/intention to become pregnant during the study
• •* Known active malignant disease (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• •* Current suspected or known injecting drug abuse (except individuals participating in a heroin substitution program without known or suspected concomitant drug abuse). Participants will be counselled regarding the risk of HCV acquisition during the trial.
• •* Seropositive for hepatitis B surface antigen (HBsAg)
• •* Positive test for Hepatitis C antibody and/or PCR
• •* Moderate neutropenia (Absolute neutrophil count of \<1,000 cells/uL)
• •* Moderate thrombocytopenia (Platelet count \<80,000 cells/uL)
• •* Anaemia (Haemoglobin \<10g/dL)
• •* History of pericarditis and/or myocarditis
• •* Heart failure (left ventricular ejection fraction \<20%) in the patient history or current medical treatment for heart failure.
• •* History of immunologically mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management)
• •* History of organ transplantation
• •* History of severe psychiatric disease, including psychosis and/or depression, characterised by a suicide attempt, hospitalisation for psychiatric disease, or a period of disability as a result of psychiatric disease.
• •* History of a significant coagulopathy (i.e. International Normalised Ratio (INR) \> 1.3 and/or Activated Partial Thromboplastin Time (APTT) \> 1.5 upper limits of normal) or anticoagulant therapy at time of vaccination
• •* Receipt of any oral or systemic antineoplastic or immunomodulatory (e.g. oral systemic corticosteroids) treatment or radiation within 24 weeks before Day 0 or the expectation that such treatment will be needed at any time during the study. Topical or inhaled corticosteroid use is allowed.
• •* Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study