Evaluation of the Safety of Simultaneous HCV and HIV-1 Immunisations
Research type
Research Study
Full title
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
IRAS ID
133442
Contact name
Lucy Dorrell
Contact email
Sponsor organisation
University of Oxford
Eudract number
2014-000730-30
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
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 co-infected 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 18-50 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) and will be asked to give a blood sample at each clinic visit.
The first injection will be AdCh3NSmut1 for participants in Group 1, ChAdV63.HIVconsv for participants in Group 2, or both AdCh3NSmut1 and ChAdV63.HIVconsv for participants in Group 3. This will be followed eight weeks later by an injection of MVA-NSmut for participants in Group 1, MVA.HIVconsv for participants in Group 2, or both MVA-NSmut and MVA.HIVconsv for participants in Group 3.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0195
Date of REC Opinion
2 Jun 2014
REC opinion
Further Information Favourable Opinion