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About
The study is aimed at assessing the safety and immunogenicity of HCV prime-boost vaccinations ChAd3-hliNSmut and MVA-hliNSmut, administered intramuscularly in healthy volunteers and DAA treated patients.
Full description
Hepatitis C currently infects more than 180 million people worldwide and is associated with the development of liver cancer, liver failure and liver cirrhosis. Although drug treatments are available these are expensive and prolonged. Furthermore patients often only present to health care professionals at late stages when liver disease has already progressed. Therefore, vaccination remains the optimal method of preventing infection. To date this has proved extremely difficult due to the enormous variation in HCV strains around the world.
Researchers at the University of Oxford in collaboration with industry, have developed novel candidate vaccines against HCV ('NSmut'). These vaccines have been inserted into the carrier viruses Chimpanzee Adenovirus (ChAd) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records. These vaccines have been given to hundreds of healthy volunteers and are now being tested for effectiveness.
In this study we are hoping to increase the immune response against the HCV virus. We will do this by inserting a gene in the vaccine (class-II invariant gene). In animal studies, this approach has been shown to be safe and to significantly to enhance the immune response against HCV.
During this study 15 healthy adults and 10 volunteers who were previously treated for HCV infection, aged 18-65 years, will receive either two intramuscular injections over a period of two months. All participants will be followed up for a further 6 months (12 visits in total) and will be asked to give a blood sample at each clinic visit.
The aims of the study are to assess the safety of the vaccine and to see if the vaccine can induce a strong immune response against the hepatitis C Virus.
Enrollment
Sex
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Volunteers
Inclusion criteria
Specific for Groups 1 and 2:
• Healthy males or females, as assessed by medical history, physical examination and laboratory tests
Specific for Group 3:
Exclusion criteria
Specific for groups 1 and 2:
Specific for group 3:
Reported current high-risk behaviour for HCV infection (previous IVDU is not an exclusion criteria for this group)
HCV RNA positive following DAA treatment
Cirrhosis or severe fibrosis (Ishak 5 or 6) as previously defined by any of the following:
Primary purpose
Allocation
Interventional model
Masking
25 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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