NCT02362217

A Study to Assess the Safety of HIV and Hep C Vaccine Candidates When Given Separately or in Combination

A Phase I Study to Evaluate the Safety and Immunogenicity of Simultaneous Prime-Boost Immunisations With Candidate HCV and HIV-1 Vaccines, AdCh3NSmut1 / ChAdV63.HIVconsv and MVA-NSmut / MVA.HIVconsv, in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is aimed at assessing the safety of candidate Hepatitis C vaccines AdCh3NSmut/MVA-NSmut and HIV vaccines ChAdV63.HIVconsv/MVA.HIVconsv when administered separately or in combination to healthy volunteers. The study also aims to assess the cellular immune response generated by these vaccines when administered as mentioned above.

Detailed description

Hepatitis C and HIV are both widespread pathogens. By the end of 2010, there were 2.3 million people in Europe living with HIV, over half of whom were coinfected with the Hepatitis C virus (HCV). Although vaccination is the optimal method of preventing infection, it has proved extremely difficult to develop an effective vaccine against HIV and HCV due to the enormous variation in strains around the world. This is caused by the extraordinary ability of the viruses to change their genetic material. Researchers at the University of Oxford have developed novel candidate vaccines against HIV ('HIV.consv') and HCV ('NSmut'). These vaccines have been inserted into the carrier viruses Chimpanzee Adenovirus (ChAd or AdCh) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records. The aim of this study is to test for the first time the response of the immune system when vaccines to both HIV and HCV are given together. During this study, 32 healthy adults aged 18 to 50 years will be recruited into one of three groups to receive either two or four intramuscular injections over a period of two months. All participants will be followed up for a further six months (12 visits in total).

Conditions

• Hepatitis C Infection
• HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	AdCh3NSmut1	Genetic vaccine against Hepatitis C virus infection
BIOLOGICAL	MVA-NSmut	Genetic vaccine against Hepatitis C virus infection
BIOLOGICAL	ChAdV63.HIVconsv	Genetic vaccine against HIV-1 infection
BIOLOGICAL	MVA.HIVconsv	Genetic vaccine against HIV-1 infection

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-08-01
• Completion: 2017-10-31
• First posted: 2015-02-12
• Last updated: 2018-10-11

Locations

1 site across 1 country: United Kingdom