Present: Professor Martin Gore, Professor Andrew Baker, Dr Kathleen Bamford, Mrs Debbie Beirne, Professor Hilary Calvert, Professor Mary Collins, Ms Claire Foster, Professor Terry Hamblin, Professor David Harrison (Vice Chair), Professor Nick Lemoine, Dr Adrian Lepper, Mrs Fiona Sandford, Dr Michael Waterhouse Co-opted: Dr Vivian Mautner
Observers: Dr David Brown (HSE), Dr Riaz Zuhire (MHRA)
Secretariat: Dr Monika Preuss, Miss Joanna Edwards, Mr Daniel Gooch and Mrs Halina Pounds.
Apologies: Professor Richard Ashcroft, Dr Peter Harris, Mr Michael Harrison, Dr Stephen Minger, Bishop Dr Lee Rayfield

Item 1: Welcome

Professor Martin Gore, the Chair, opened the meeting by welcoming members to the 64th GTAC meeting. He informed the Committee that Dr Vivian Mautner had been co-opted onto the Committee for the day due to her expertise in Infectious Disease.

Item 2: Minutes of the 65th meeting of GTAC

The minutes were agreed as an accurate and true record of the 65th meeting.

Item 3: Matters Arising

A number of letters had been sent out, and received, concerning correspondence arising from the last meeting. There were no comments.

Item 4: Chairman's Actions

Six letters had been sent out under Chairman's Actions since the last meeting, none of which gave rise to any discussion.

Item 5: New Protocol GTAC 145: A randomised open labelled, Phase II, immunogenicity and exploratory efficacy evaluation of therapeutic immunisation +/- IL-2, GM-CSF and growth hormone in HIV-1 infected subjects receiving highly active anti retroviral therapy (HAART)

Human Immunodeficiency Virus (HIV) is the agent responsible for Acquired Immunodeficiency Syndrome (AIDS). Highly active antiretrovial therapy (HAART) has had significant impact on HIV infection in the developed world, however, one of the problems with this treatment is the gradual loss of HIV-1 specific CD8+ cells following HAART-induced viral suppression.

The Committee discussed this study in detail before deciding to give Conditional Approval.

Item 6: New Protocol GTAC 144: A Phase 1 study to assess the safety and immunogenicity of new Hepatitis C virus vaccine candidates AdCH3NSmut and Ad6NSmut

Hepatitis (inflammation of the liver) can be caused by a variety of different reasons from drug or alcohol inducement to viral hepatitis. Hepatitis C is one of about seven other identified viral hepatitis.

There are two candidate vaccines for Hep C, Ad6NSmut and AdCh3NSmut that are to be studied in this trial.

The Committee spent some time in discussing this trial before giving conditional approval.

Item 7: New Protocol GTAC 143: A Phase 1 study to assess the safety and immunogenicity of a new influenza vaccine candidate MVA-NP+M1 in healthy adults

This application is a vaccine for influenza. The team propose to use a recombinant modified vaccinia virus Ankara (MVA) as a carrier for an immunotherapy vaccine. The vector encodes the nucleoprotein (NP) from H3N2, which is necessary for virus replication, and is fused with an influenza envelope protein (MP1). There is little variation in these two proteins between influenza viruses so it is hoped it will provide a good vaccination strategy.

The Committee discussed this protocol before giving approval.

Item 8: Presentation on the Human Tissue Act

The Committee received a training presentation on the Human Tissue Act.

Item 9: Re-Approval of GTAC 98: A Phase 1 study of lentivirus transduced acute myeloid leukaemic cells (AML) expressing B7.1 (CD80) and IL-2 for the potential enhancement of graft versus leukaemia (GvL) effect in poor prognosis AML

This application is a re-submission of a study which was approved by GTAC in November 2004. MHRA approval was only obtained earlier this year which means that three years have elapsed without patient enrolment into the study.

Since the Committee last reviewed the protocol there have been some protocol modifications requested by the MHRA. The Committee was requested to re-review this trial in light of ethical approval having elapsed, and also to discuss if members are content with the proposed amendments to the trial.
The Committee gave Approval for this study.

Item 10: Re-Approval of GTAC 128: WT1 TCR Gene Therapy of Leukaemia: A Phase I/II Safety and Toxicity Trial

An application had been made for the re-approval of another leukaemia trial, GTAC study 128 which received conditional approval in December 2006.

The Committee Approved this trial.

Item 11: GTAC Workshop on 28 January 2008

Amendments are proposed to the Clinical Trials Regulations which will affect the role of GTAC under the Regulations. The intention is to enable some applications that currently come to GTAC to be delegated to another NHS REC thereby creating the necessary resources so that GTAC can act on the Government's wish for it to review other forthcoming research (eg stem cells) and also spend more time on its role as an advisory body.

The half-day workshop will comprise a number of GTAC members, key GTAC stakeholders and experts in gene therapy to decide which 'low-risk' gene therapy trials would be suitable for delegation to another NHS REC. The group's views will be presented to GTAC for discussion at its meeting on 20 February.

Item 12: For Information: GTAC Education Day

The Secretariat informed the Committee that the day was an extremely successful event with almost full attendance of approximately 150 GCSE and A-level students attending accompanied by teachers.

Warm thanks were extended to Prof David Harrison for chairing the event, and to Prof Mary Collins, Dr Richard Ashcroft and Ms Debbie Beirne for giving their time and the effort they put into their presentations and also (in Prof Collins' case) for escorting a group round her labs.

Item 13: SUSARs

The Committee noted the 13 new SUSARs reported since the previous meeting.

Item 16: Any Other Business

• GTAC 045: SUSAR ON X-SCID TRIAL

Recently a boy on the UK X-SCID study has developed leukaemia, most probably as a result of the gene therapy and Committee members were circulated with a copy of the original SUSAR report as well as a follow up notification.

Item 14: Press Cuttings

NEXT MEETING: Wednesday, 20 February 2008

GTAC Secretariat
March 2008

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