Present: Professor Norman Nevin (Chair), Mrs Debbie Beirne, Professor Martin Gore, Professor Terry Hamblin, Professor Jim Neil, Rev Dr Lee Rayfield, Dr Adrian Lepper, Dr Richard Ashcroft, Professor Andrew Lever (not Item 10), Dr Caroline Benjamin, Mr Michael Harrison, Mrs Fiona Sandford, Professor Alex Markham (Item 10 only), Dr Peter Harris, Professor David Harrison, and Dr Michael Waterhouse.

Secretariat: Dr Monika Preuss, and Mr Daniel Gooch.

Item 1: Introduction

The Chair welcomed the Committee to its third meeting of 2004. The Chair congratulated Professor Gore and Mr Harrison on their appointments by Lord Warner as Vice Chair, and Alternate Vice Chair, respectively. These two appointments bring GTAC in line with the provisions of the new Clinical Trials Regulations.

Item 2: Minutes of the 47th meeting of GTAC

The minutes were agreed as an accurate and true record of the meeting. Some updates on minor issues from the last meeting were provided.

Item 3: Matters Arising

Correspondence. Several letters had been sent concerning correspondence arising from the last meeting. There was a short discussion on SAE reporting.

Oral update on the White Paper commitments. Regarding the £4 million vector production commitment, the Secretariat had tabled an advert, and corresponding form, announcing a call for expressions of interest for this support.

Item 4: A 2x2 Factorial Randomised Phase II Trial Assessing Anti-CEA, Anti-MUC-1 Vaccination after Surgery in Patients with Stage II Colorectal Cancer

This is a phase II trial of immunotherapy in patients with stage II colorectal cancer. The study product consists of two vectors, one derived from vaccinia virus and the other derived from fowlpox virus. Both vectors contain the same gene load, namely the tumour antigens carcinoembryonic antigen (CEA) and Mucin-1 (MUC-1), plus three co-stimulatory proteins. The protocol describes a prime-boost regime of injections with the vaccinia followed by the fowlpox vector. There are 4 treatment groups who receive the vaccinations and/or chemotherapy and/or GM-CSF.

The proposers joined the Committee for a presentation and Q+A session. After some discussion, GTAC decided to approve the trial subject to making a few minor amendments to the protocol, PIL, and consent form.

Item 5: Temporary halt of the DNA/MVA anti-HIV trials at Oxford

GTAC had been informed that recruitment into the above HIV vaccination studies has been interrupted voluntarily. This is due to potential concerns over the safety of the study products which have come to light in the context of two recent pre-clinical studies with two new vectors. Full reports from these studies were now available and had been sent to GTAC.

The principal investigator and a representative from the sponsoring company joined the Committee for a discussion of the two reports. In discussion, the Committee agreed that the findings from the two pre-clinical studies did not raise any safety concerns with the ongoing studies at Oxford. GTAC was content for the trials to resume.

Item 6: Chairman's Actions

Since the last GTAC meeting, six Chairman's Actions had been taken, none of which gave rise to any discussion.

Item 7: SAE update

Four new SAEs had been received since the last meeting. There were no comments. Results of a post-mortem had also been recevied which confirmed that cause of dealth was multifactorial and related to disease progression.

Item 8: Any other business

Oral update on the Public Meeting. The Secretariat had produced a final programme and promotional flyer for the public meeting in Cambridge on Tuesday 20 July.

Guidance notes on writing patient information leaflets. GTAC's current guidance notes on patient information leaflets were reproduced in the standard operating procedures. The committee considered that it would be helpful to update this guidance. The Secretariat was asked to compile relevant material.

Item 9: GTAC antisense workshop

The GTAC antisense workshop took place on 12 May. Various applications of antisense technologies in clinical trials aimed at silencing or modifying genes were discussed. The Committee decided that all antisense trials should continue to require review by GTAC. The draft minutes of the workshop were approved as an accurate and true record by those members who had attended the meeting.

There was a discussion about the proposed text for the revised definition of gene therapy and associated guidance, and a revised text was agreed.

The Committee also decided that would no longer be appropriate to continue with the notification system that had been used for some genetic vaccine trials in healthy volunteers.

Item 10: GTAC 93: An open, randomised, parallel group study to evaluate the safety, tolerability and immunogenicity of GW825780 DNA immunotherapeutic in healthy adult volunteers

This was an application for a DNA immunotherapeutic vaccine trial in healthy volunteers. The study product is plasmid DNA, called GW825780, which is coated onto the surface of microscopic gold particles. The DNA contains multiple HIV antigens derived from three HIV proteins, reverse transcriptase, Gag and Nef. The resulting plasmid encodes most of the epitopes in gag, RT and Nef. This is hoped to cover HIV-1 strains A, B, D and F, which are the most prevalent strains in America, Europe, Australia and sub-Saharan Africa. The vaccine is "glued" (immobilised) onto microscopic gold particles. These are then projected into the skin by using a helium pressurised delivery system.

Representative from the sponsoring company and the principal investigator joined the Committee for a presentation and Q+A session. After some discussion, GTAC decided to approve the trial and made some additional recommendations.

Press cuttings

A small number of press cuttings were included with the papers, but nothing of particular note.

Next meeting:

Public Meeting: Tuesday 20 July 2004 in Cambridge
Committee Meeting: Wednesday 21 July 2004 in Cambridge.

GTAC Secretariat
July 2004

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