Present: Professor Norman C Nevin (Chair), Ms Caroline Benjamin, Mrs Debbie Beirne, Professor Martin Gore, Professor Terry Hamblin, Dr Peter Harris, Professor David Harrison, Mr Michael Harrison, Professor Nick Lemoine, Professor Andrew Lever, Professor Alex Markham, Professor James Neil, Dr Michael Waterhouse.

Observers: None.

Secretariat: Dr Jayne Spink, Dr Monika Preuss, Mrs Margaret Straughan, Mr Daniel Gooch.

Item 1. Welcome and Apologies.

The Chair welcomed Members to the 42nd Meeting of GTAC. He also welcomed Dr Monika Preuss who had attended the last meeting as an observer and who has now joined the Secretariat. Apologies had been received from Mr David Crosby, Mrs Fiona Sandford, Revd Dr Lee Rayfield and Dr Philip Harrison (MHRA).

Members were informed that Professor Nevin had agreed to serve a third term as Chairman. Professors Andrew Lever, Alex Markham, David Harrison and Revd Dr Lee Rayfield have also agreed to serve another term.

Members were informed that the recommendations drawn up by the GTAC/CSM working party on retroviral safety had been published on the GTAC Website on Tuesday, 13 May 2003.

Item 2. Minutes of the 41st Meeting of GTAC.

Following minor amendments, the minutes of the 41^st meeting were accepted as a true and accurate record.

Item 3. Matters Arising.

The 9^th Annual Report was published on Monday, 12 May 2003. A pdf version of the report is available on the GTAC Website.

The Clinical Trials Regulations will come into force from 1^st May 2004. Members were asked to finalise the response to the consultation on the draft regulations.

Item 4. Protocol: Evaluation of the safety and immunogenicity of MVA.HIVA vaccine in HIV-seropositive HAART-treated subjects. John Radcliffe Hospital Oxford.

This is a phase I trial of a DNA vaccine for HIV-1 positive patients who are receiving highly active anti-retroviral therapy (HAART). The vector is based on Modified Vaccinia Ankara virus which was used extensively as a vaccine in the 1970s for smallpox eradication programmes. After a short presentation by the proposers and discussion by Members, it was agreed to grant approval to this protocol subject to a slight revision of the inclusion criteria and patient information leaflet.

Item 5. Protocol: Dendritic cells transduced with ImmunoVEX^tri-melan to patients with metastatic or inoperable melanoma. St George's Hospital Medical School, London.

This trial is a vaccination study using a study product derived from herpes simplex virus. The investigators aim to immunise patients against melanoma specific antigens in an attempt to simulate the immune response against cancer cells. After a short presentation by the proposers and discussion by Members, it was decided to decline this proposal but that the proposers should be invited to submit the protocol with more data and to resubmit this to GTAC in due course.

Item 6. Protocol: A phase II trial to evaluate efficacy and safety of intramuscular injections of HER-2 DNA AutoVax^TM in patients with metastatic or locally advanced breast cancer. Hammersmith Hospital, London.

This is a phase II trial which follows on from GTAC 057 which was approved in September 2001. The investigators propose to immunise patients with a vaccine which consists of DNA for Human Epidermal Growth Factor Receptor 2 (HER-2). It is hoped that this will stimulate the immune response to destroy breast cancer cells expressing HER-2. After a short presentation by the proposers and discussion by Members, it was agreed to give approval for this protocol but to draw the proposers attention to some minor amendments in the patient information leaflet and to request minor clarifications in the study protocol.

Item 7. Open Meeting.

The European Society for Gene Therapy will be holding their annual conference in Edinburgh in November 2003. GTAC is involved in two ways. Firstly, it is sponsoring a scientific session on retroviral safety. Secondly, GTAC will run a parallel open session. Members were asked for ideas for this session.

Item 8. Chairman's Actions.

Approvals and amendments to pre-existing proposals which had taken place via Chairman's Actions since the last GTAC meeting were brought to the attention of members, who were ask if they had any comments. No objections/comments were made.

Item 9. Serious Adverse Event Update.

Members considered the Serious Adverse Events (SAE) data table which had been extended to incorporate new SAEs since the last meeting. Members requested to seek further details on those SAEs where a relationship with the study product had been suggested. These will be discussed in the 43^rd GTAC meeting.

Item 10. Any Other Business.

Members were asked to comment on the potential use of Adeno-associated viral vectors in gene therapy trials in the UK. It was confirmed that, provided the known safety issues with this type of vector are addressed adequately, no objections would be raised to the use of AAV vectors in principle.

Finally, members attention was drawn to a tabled paper inviting membership of the newly formed British Society for Gene Therapy. Members were asked to note that BSGT will be holding a meeting, hosted by the BBSRC on 26^th June 2003.

GTAC Secretariat
May 2003

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