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

Item 1: Welcome

Professor Martin Gore, the Chair, opened the meeting by welcoming members to the 64th GTAC meeting. He informed the Committee that Professor David Harrison, as vice-Chair, would be chairing the afternoon session.

Item 2: Minutes of the 63rd meeting of GTAC

The minutes were agreed as an accurate and true record of the 63rd meeting.

Item 15: Any Other Business: CGD Study (GTAC 046)

The team at GOSH had come forward with a request to enrol a new patient onto this trial. The Committee discussed whether there was any new information that had come to light that would affect the acceptability of new patient enrolment.

The Committee approved enrolment of the new patient on to this study.

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

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

Item 15: Any Other Business: Substantial Amendment GTAC 118

This item concerned a substantial amendment for GTAC 118 (TB vaccine in HIV positive individuals).

The Committee approved this substantial amendment.

Item 5: New Protocol GTAC 135: A randomised double blind placebo controlled study to evaluate the safety and immunogenicity of a candidate HIV-1 vaccine, MVA.RENTA, delivered intradermally by needle injection, alone or in combination with MVA.HIVA, to HIV 1 seropositive adult subjects receiving Highly Active Antiretroviral Therapy (HAART)

Human Immunodeficiency Virus (HIV) is the agent responsible for Acquired Immunodeficiency Syndrome (AIDS). Once infected, the virus replicates and spreads through the immune system. The virus depletes cells, called T lymphocytes, of the immune system which are responsible for fighting infections. Such loss of immune system activity exposes those infected to opportunistic infections and tumour formation. HIV infection in humans is now classed as a pandemic.

There was a short discussion on this trial before approval was given.

Item 6: New Protocol GTAC 137: A randomised, open labelled, phase II non inferiority clinical study between two manufacturing processes for the tuberculosis vaccine, MVA85A.

Tuberculosis (TB) is an airborne disease with increasing numbers of infections worldwide. This study is designed for healthy volunteers but the majority of new infections of TB are in those also infected with HIV.

The Committee briefly discussed this protocol before giving approval.

Item 7: Substantial Amendment GTAC 096: A Cancer Research UK phase I trial of adoptive transfer of autologous tumour antigen specific T cells with pre-conditioning chemotherapy and intravenous IL2 in patients with advanced CEA positive tumours [and]

Item 8: Re-review GTAC 103: A phase I study of CD19 specific T cells in CD19 positive malignancy

These two related items were taken together. The studies are similar in so far as the applicant is the same Chief Investigator and the vectors are identical bar for the transgene.

GTAC 096 was originally approved in 2004 and re-reviewed by the Committee in December 2006 and GTAC 103 was first approved in June 2005. Both approvals were over two years ago and as such have elapsed.

The Committee discussed these protocols in some detail before giving approval to them both.

Item 9: SUSARs

The Committee noted the 9 new SUSARs received since the previous meeting. There were no comments.

Item 10: Closure of the GTAC/DH Flagging Project

The Committee briefly reviewed the closure of the DH/ GTAC flagging project. The Committee again supported the idea of a publication of the findings, for instance in Human Gene Therapy.

Item 12: Presentation on Consent

This item was postponed until October.

Item 13: Consultation - Update to the Code of Practice for Scientific Advisory Committees

The Committee had a brief discussion around each of the four questions asked by DIUS, which mostly covered the definition of a lay member and monitoring of the Scientific Advisory Committee. The Secretariat agreed to write a response.

Item 14: Consultation - Proposed voluntary accreditation scheme for phase I clinical trial units

The Committee was informed of a consultation from the MHRA and was requested to forward comments to the Secretariat by the end of July.

Item 15: Any Other Business: GTAC public meeting

BSGT has approached GTAC to ask whether it would be interested in being involved in BSGT's 'education day' which will run on the day before BSGT's annual conference in April 2008 in Edinburgh.

Members briefly discussed the proposal and agreed that it would be a good idea to work with BSGT on the event.

Item 11: New Protocol GTAC 136: Investigation of the safety and feasibility of SERA gene transfer in the human failing heart using an adeno-associated viral vector

The Chair, Professor Martin Gore, was unavailable during the afternoon session and so Professor David Harrison, the Vice Chair, chaired this session.

The study aims to try a novel gene therapy strategy for patients with heart failure. Patients eligible for this trial have had advanced heart failure and have received a Left Ventricular Assist Device (LVAD).

The Committee discussed this trial in some detail before approval was given.

Item 11: Press Cuttings

There was no discussion of the press cuttings.

NEXT MEETING: Wednesday, 3 October 2007

GTAC Secretariat
September 2007

Top

copyright: © | last updated 27 March 2007