HCV003_Study of a new MVA vaccine for hepatitis C virus_v1

• Research type

  Research Study

• Full title

  A Phase I study to assess the safety and immunogenicity of AdCh3NSmut and MVA-NSmut in healthy volunteers and patients with hepatitis C virus infection

• IRAS ID

  53435

• Contact name

  Eleanor Barnes

• Sponsor organisation

  Reithera

• Eudract number

  2009-018260-10

• ISRCTN Number

  n/a

• Research summary

  Currently there is no vaccine available for either the prevention (prophylactic vaccination) or the treatment (therapeutic vaccine) of HCV and the treatment of HCV with the best available therapy (pegylated-interferon-alpha (PEG-IFN) and ribavirin) has significant side effects and is frequently ineffective and poorly tolerated. The majority of patients in the UK have a particular type of HCV virus (genotype 1) and only 50% of these patients respond to PEG-IFN and ribavirin. The purpose of this study is to understand if the candidate therapeutic vaccine (AdCh3NSmut and MVA-NSmut) we want to develop is safe and able to generate an immune response against the hepatitis C virus when injected in healthy and hepatitis C infected patients. The study will be conducted at three sites: the John Radcliffe Hospital, Headington, Oxford, the Centre for Clinical Vaccinology and Tropical Medicine Headington Oxford, and the Wellcome Clinical Research Facility, Queen Elizabeth's Hospital, Birmingham. The study will involve 23 patients, divided into three Arms (A, B and C). In Arm A volunteers without HCV infection (healthy volunteers) will be divided in Group A1 (n=4) and Group A2 (n=5). Group A1 will receive a single vaccination with MVA-NSmut. Group A2 will receive two vaccinations, 1 of AdCh3NSmut and 1 of MVA-NSmut. Arm B involves patients with HCV receiving current gold-standard anti-hepatitis C therapy (PEG-IFN and ribavirin). In Arm B1 (n=5) patients receive 2 vaccinations 8 weeks apart, beginning after viral load has dropped (weeks 14 and 22). In Arm B2 (n=5) patients receive the same vaccinations but early on in treatment (Weeks 2 and 10). Arm C (n=4) consists of one group (C1) of patients with HCV not on treatment who receive two vaccinations 8 weeks apart. Safety and immune response of each Arm will be assessed.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/45

• Date of REC Opinion

  18 Jun 2010

• REC opinion

  Favourable Opinion