This study is aimed at assessing the safety of candidate Hepatitis C (Hep C) vaccines AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV) seropositive individuals. This study also aims to assess the cellular immune response generated by these vaccines when administered as mentioned above.
Hepatitis C (Hep C) is a common infection. Worldwide, over 180 million people are infected. Hep C is a blood borne viral infection spread through direct contact with the blood of an infected person. People with Hep C frequently have no symptoms and infection can lead to fibrosis (scarring of the liver), liver failure and cancer. Infection with the Hep C virus (HCV) progresses more rapidly to liver damage in Human Immunodeficiency Virus (HIV)-infected individuals. Researchers at the University of Oxford have developed a novel candidate vaccine against HCV ('NSmut'). This vaccine has been inserted into the carrier viruses Chimpanzee Adenovirus 3 (AdCh3) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records and have been previously tested in people. However, the objective of this study is to use exploratory immunological assays to assess whether vaccines for Hep C can induce immune responses in HIV positive individuals that are similar in strength to those in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Genetic vaccine against Hepatitis C virus infection
Genetic vaccine against Hepatitis C virus infection
St James's Hospital
Dublin, Ireland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Safety of administering HCV prime-boost vaccinations to HIV seropositive individuals, as measured by the proportion of participants who develop a grade 3 or 4 local or systemic reaction
Time frame: From Day 0 until 6 months after the last vaccination
Cellular immune response generated by HCV prime-boost vaccinations in HIV seropositive individuals, as determined by analysing changes in the magnitude or quality of HCV-specific cellular immune responses
Immunogenicity determined by analysing changes from baseline in the magnitude or quality of HCV-specific cellular immune responses. The primary outcome measure for immunogenicity will be the development of T cell responses to HCV epitopes, as determined by Interferon (IFN)-ɣ Enzyme-Linked ImmunoSpot (ELISpot) assay.
Time frame: From Day 0 until 6 months after the last vaccination
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