NCT02568332

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

A Phase I Study to Assess the Safety and Immunogenicity of Prime-boost Immunisations With Vaccine Candidates AdCh3NSmut1 and MVA-NSmut in HIV-1 Seropositive HCV-uninfected Adults on Antiretroviral Therapy (ART)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis C Infection

Interventions

Type	Name	Description
BIOLOGICAL	AdCh3NSmut1	Genetic vaccine against Hepatitis C virus infection
BIOLOGICAL	MVA-NSmut	Genetic vaccine against Hepatitis C virus infection

Timeline

• Start date: 2015-07-21
• Primary completion: 2017-01-26
• Completion: 2017-10-31
• First posted: 2015-10-05
• Last updated: 2018-10-11

Locations

2 sites across 2 countries: Ireland, Switzerland