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, Ms Claire Foster, Professor Hilary Calvert, Dr Michael Waterhouse and Mrs Fiona Sandford, co-opted: Dr Colin Stewart (Item 7)
Secretariat: Dr Monika Preuss and Miss Joanna Edwards
Observers: Dr Riaz Zuhrie (MHRA), Dr Brian Shine (Items 4 and 5).
Apologies: Dr Sharon Longhurst (MHRA), Professor Nick Lemoine, Dr Paul Logan (HSE) and Mr Daniel Gooch (Secretariat)

Item 1: Welcome

Professor Martin Gore, the Chair, opened the meeting welcoming members to the 63rd GTAC meeting.

Item 2: Minutes of the 62nd meeting of GTAC

The minutes were agreed as an accurate and true record of the 62nd meeting.

Item 3: Matters Arising

A number of letters had been sent out, and received, concerning correspondence arising from the last meeting.

Item 4: Chairman's Actions

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

Item 5: New Protocol GTAC 134: Measurement of human T-cell turnover following vaccination with the Tuberculosis vaccine MVA85A

Tuberculosis (TB) is an airborne disease with increasing numbers of infections worldwide. This is a healthy volunteer study to investigate the T-cell kinetics.

The Committee had a short discussion of this protocol and approved the trial subject to minor amendments.

Item 6: New Protocol GTAC 133: A phase I study to assess the safety and immunogenicity of a new candidate Malaria vaccine, AdCh63 mE-TRAP alone and with MVAmE-TRAP, using a prime boost delivery schedule

Malaria is the most important tropical disease around today.

This study is for healthy volunteers and proposes to use a novel vector based upon a recombinant chimpanzee adenovirus 63. The study is a dose escalation study with the primary objective to assess safety.

The Committee discussed this trial and decided that they were unable to approve the trial during the meeting. Opinion on this trial was therefore deferred until more information was available.

Item 7: New Protocol GTAC 132: Gene Therapy for SCID X1 using a self inactivating (SIN) gammaretroviral vector

X-SCID is an inherited disorder causing the boys affected to become extremely susceptible to all types of infections.

This is the second SCID X1 trial the Committee has seen, the previous one was in 2001. The main difference from 2001 is that there is a new vector, which is based on a gamma-retrovirus with a self-inactivating (SIN) configuration.

There have been difficulties with a similar trial in France where 4 children have developed Leukaemia. Fortunately, to date, no UK children had experienced such complications. The Committee was careful therefore to reassess the risk-benefit for X-SCID boys in light of the French cases and in light of treatment options for the children through bone marrow transplant. To this end, the Secretariat had invited Dr Andrew Gennery from Newcastle University to brief the Committee on treatment outcomes for X-SCID patients at Newcastle.

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

Item 8: SUSAR Update

GTAC reviewed the new SUSARs that had been received since the previous meeting.

Item 9: Consultation on the draft guidelines for phase I clinical trials by the Association of the British Pharmaceutical Industry

The Committee were asked to send in any comments on the above consultation to the Secretariat.

Item 10: Any Other Business

Substantial Amendment GTAC 73: A phase I clinical gene therapy protocol for Adenosine Deaminase Deficiency

There was only one item under any other business. A substantial amendment had been received for another GOSH trial for ADA-SCID.

The Committee was content and approved the amendment.

Item 11: Press Cuttings

There was no discussion of the press cuttings.

NEXT MEETING: Wednesday, 18 July 2007, Wellington House

GTAC Secretariat
June 2007

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