Present: Professor Norman C Nevin (Chair), Ms Caroline Benjamin, Mr David Crosby, Professor David J Harrison, Mr Michael Harrison, Mrs Ann Hunt, Professor Alex Markham, Revd Dr Lee Rayfield, Mrs Fiona Sandford, Dr Michael Waterhouse

Observers:Dr Philip Harrison (MCA), Ms Liz Woodeson (DH)

Secretariat: Dr John Connolly, Dr Jayne Spink, Mrs Margaret Straughan, Mr Daniel Gooch

Item 1. Welcome and Apologies

The Chairman welcomed Members to the 37th Meeting of GTAC. The Chairman commented on the recent press coverage of a child treated for X-SCID at Great Ormond Street Hospital and on the recent successful GTAC forum on Lentiviruses and Conditionally Replicating Viruses. Apologies had been received from Professors James Neil, Andrew Lever, Ian Hart and Dr Lincoln Tsang. Professor Terry Hamblin had declared an interested in the protocol that the Members would be discussing and he felt it inadvisable to be present.

Item 2. Minutes of 36th meeting.

These had been circulated to Members. After minor amendment, the Minutes were accepted as a true record. Later clarification was requested by the Medicines Control Agency (see Note of 37^th meeting).

Item 3. Protocol:

Phase I/II study of vaccination with a DNA fusion gene containing an epitope of Cytomegalovirus (CMV) in allograft donors and patients awaiting renal transplantation.

University of Southampton.

The Chair outlined the background of this protocol. The study would target two patient groups, those with haematological cancers (whose donors would be vaccinated) and those awaiting kidney transplants. The vast majority of adults are infected with CMV in childhood, adolescents or early adult life without significant medical consequences. Despite immune system control, the virus remains dormant in the individual. New infections of CMV or reactivation of latent virus in immunosuppressed individuals can lead to serious problems. The proposers aim is to use a DNA strategy to enhance an immune response against CMV. After a short presentation by the proposers and discussion by Members, it was agreed that the protocol would be split into two separate studies: one for vaccination of stem cell transplant donors and recipients and the other for renal patients. The "stem cell" trial was granted conditional approval. An application to re-submit a proposal to conduct the study in the renal transplant setting was invited.

Item 4. Chairman's Actions:

Approvals and amendments to pre-existing proposals which had taken place via Chairman's Actions between the 36^th and 37^th GTAC meetings were brought to the attention of members, who were ask if they had any comments.

Item 5. Any Other Business:

Members considered Serious Adverse Events that had been reported to the secretariat since the last meeting. Issues surrounding the suitability of gene therapy research sites were considered and discussed. The secretariat discussed the outcomes from the GTAC open meeting on Cancer and forum on novel viral vectors in gene therapy. A regulatory "route-map" for gene therapy researchers was to be established in conjunction with the MCA.

GTAC Secretariat

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