Present: Professor Norman C Nevin (Chair), Mr David Crosby, Professor Martin Gore, Professor Terry Hamblin, Professor David Harrison, Mr Michael Harrison, Mrs Ann Hunt, Professor Andrew Lever, Professor Alex Markham, Professor James Neil, Reverend Dr Lee Rayfield, Dr Michael Waterhouse.

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

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

Item 1. Welcome and Apologies.

The Chairman welcomed Members to the 36th Meeting of GTAC. Members were informed that Mrs Irene Train had resigned from the Committee due to personal commitments. Apologies had been received from Ms Caroline Benjamin, Mrs Fiona Sandford and Professor Ian Hart. The Chair welcomed Mr Daniel Gooch who had joined the Secretariat from the Biotechnology Unit in the Department of Health.

Item 2. Minutes of 35th meeting.

These had been circulated to Members. This also applied to Professor Ian Hart. After minor amendment, the Minutes were accepted as a true record.

Item 3. Protocol:

Recombinant Modified Vaccinia Ankara (MVA)-based vaccine encoding Epstein-Barr Virus target antigens; phase I dose escalation trial to determine immunogenicity and toxicity in patients with EBV+ malignancy.

Dr Neil Steven, Institute for Cancer Studies, University of Birmingham.

The Chair advised Members of the background to this protocol. Epstein-Barr Virus (EBV) infection is extremely common. Occasionally, EBV infection can lead to various forms of cancer such as Hodgkin's disease, Burkitt's lymphoma and post transplant lymphoma disease (PTLD). EBV is also implicated in nasopharyngeal carcinoma, one of the most common cancers in South East Asia. The proposers are attempting to develop a genetic vaccination strategy to enhance the immune system responses to EBV positive malignancies. The proposers gave a short presentation to the committee and answered their questions. Afterwards, following a short discussion, it was agreed to grant the study approval on the condition that minor changes were made to the patient information.

Item 4. Chairman's Actions:

Approvals and amendments to pre-existing proposals which had taken place via Chairman's Actions between the 35^th and 36^th GTAC meetings were brought to the attention of members, who were ask if they had any comments.

Item 5. Any Other Business:

Serious Adverse Events which had been reported to the secretariat were considered by members. The secretariat reported on a pre-proposal discussion with a group of researchers who wished to conduct fetal gene therapy. The outcome of a meeting of GTAC members with the Academy of Medical Sciences on DNA vaccination was discussed. Interaction between the Central Office for Research Ethics Committees and GTAC was highlighted. Members were asked for input on gene therapy issues for the forthcoming Genetics Green Paper. The secretariat informed members of preparations for the open meeting on Cancer and the forum of viral vectors.

GTAC Secretariat
March 2002

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