Latest Heptatitis C Clinical Trial 2014 - G0536-01
G0536-01 Final Report
Final Report for clinical trial G0536-01, November 2018
Year: 2018
This is the final report on the Hepatitis C vaccine trial. The report details an overview of the clinical trial, a protocol synopsis, ethical and regulatory approvals, description of the investigational products, the study population, characteristics of the release and the result of the clinical trial with respect to primary (safety) and secondary (immunogenicity) endpoints.
G0536-01 GMO Register Entry
Year: 2014
The GMO Register entry provides significant details of the clinical trial.
Board Minute Extract
Year: 2014
An extract from the minutes of the EPA Board Meeting of 8 July 2014, at which The GUIDE Department's notification seeking consent to carry out a clinical trial at St James's Hospital, Dublin, was discussed.
G0536-01 Inspector's Report
Year: 2014
All documentation submitted in respect of this notification was taken into consideration by the EPA Inspector in her report to the Board of the Agency.
Summary Notification Information Format (SNIF) AdCh3NSmut1
Year: 2014
Summary Notification Information Format (SNIF) for Modified recombinant virus vaccine AdCh3NSmut1
How to make a Representation
Year: 2014
How to make a Representation to the EPA regarding Deliberate Release G0536-01
Environmental Risk Assessment for AdCh3NSmut1
Year: 2014
Environmental Risk Assessment for Modified recombinant virus vaccine AdCh3NSmut1
Summary Notification Information Format (SNIF) for MVA-NSmut
Year: 2014
Summary Notification Information Format (SNIF) for Modified recombinant virus vaccine MVA-NSmut
G0536-01 Consent Conditions
Year: 2014
G0536-01 Consent Conditions issued to The GUIDE Department, St. James's Hospital, Dublin on 22 July 2014 for a clinical trial using a Genetically Modified Organism (GMO)
Newspaper Notice, Southside People, 16 April 2014
Year: 2014
Newspaper Notice, Southside People, 16 April 2014
Environmental Risk Assessment for MVA-NSmut
Year: 2014
Environmental Risk Assessment for Modified recombinant virus vaccine MVA-NSmut