Latest Heptatitis C Clinical Trial 2014 - G0536-01

in: Genetically Modified Organisms
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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.

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G0536-01 GMO Register Entry

Year: 2014

The GMO Register entry provides significant details of the clinical trial.

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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.

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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.

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Summary Notification Information Format (SNIF) AdCh3NSmut1

Year: 2014

Summary Notification Information Format (SNIF) for Modified recombinant virus vaccine AdCh3NSmut1

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How to make a Representation

Year: 2014

How to make a Representation to the EPA regarding Deliberate Release G0536-01

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Environmental Risk Assessment for AdCh3NSmut1

Year: 2014

Environmental Risk Assessment for Modified recombinant virus vaccine AdCh3NSmut1

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Summary Notification Information Format (SNIF) for MVA-NSmut

Year: 2014

Summary Notification Information Format (SNIF) for Modified recombinant virus vaccine MVA-NSmut

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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)

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Newspaper Notice, Southside People, 16 April 2014

Year: 2014

Newspaper Notice, Southside People, 16 April 2014

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Environmental Risk Assessment for MVA-NSmut

Year: 2014

Environmental Risk Assessment for Modified recombinant virus vaccine MVA-NSmut