NCT03688061

Class II Invariant Chain HCV Vaccine Study

A Phase-I Dose-Escalation Study to Evaluate the Safety and Immunogenicity of Prime-Boost Immunisations With Candidate HCV Vaccines, ChAd3-hliNSMut and MVA-hliNSMut in Healthy Volunteers and Patients Previously Chronically Infected With HCV

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
BIOLOGICAL	ChAd3-hliNSmut	Attenuated chimpanzee adenovirus (ChAd) vectored vaccine against HCV
BIOLOGICAL	MVA-hliNSmut	Modified Vaccinia Ankara (MVA) vectored vaccine against HCV

Timeline

• Start date: 2017-12-04
• Primary completion: 2019-08-04
• Completion: 2022-08-04
• First posted: 2018-09-27
• Last updated: 2023-05-10

Locations

2 sites across 1 country: United Kingdom