Clinical Trial to test Hepatitis C Vaccines 2014

On 22 July 2014, the EPA granted consent to the GUIDE Department (Department of Genito Urinary Medicine and Infectious Diseases), St James's Hospital, Dublin 8, to carry out a clinical trial, involving the administration of a Genetically Modified organism (GMO), in the Wellcome Trust HRB Clinical Research Facility in St James's Hospital, Dublin.

Objective of the clinical trial

The objective of this proposed trial will be to assess recombinant Hepatitis C vaccines in Human Immunodeficiency Virus-1 (HIV-1) seropositive individuals on antiretroviral therapy, who are Hepatitis C virus unaffected.

Location and Duration

The proposed trial will take place at the Wellcome Trust HRB Clinical Research Facility at St James's Hospital, Dublin 8, during the period July 2014 - December 2015.  Consent was granted, subject to conditions.

Legislation

Any person or organisation proposing to carry out a deliberate release of a genetically modified organism (GMO) for purposes other than placing on the market (performance of clinical trials) must comply with the legislative requirements set out under Part II of the GMO (Deliberate Release) Regulations S.I. No. 500 of 2003.

GMO Register Entry

The proposed clinical trial has been assigned GMO Register No G0536-01.  The Register provides significant details about the trial.  The relevant entry will be updated as details become available.

Relevant Documentation

Consent Conditions

Inspector's Report

Board Minute

GMO Register Entry