Present: Professor David Harrison (Chair), 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, Professor Nick Lemoine, Bishop Dr Lee Rayfield and Dr Kathleen Bamford
Secretariat: Dr Monika Preuss, Mr Daniel Gooch and Miss Joanna Edwards
Observers: Dr Sharon Longhurst (MHRA) and Dr Riaz Zuhrie (MHRA)
Apologies: Professor Martin Gore, Ms Claire Foster, Professor Hilary Calvert, Dr Michael Waterhouse, Mrs Fiona Sandford and Dr Paul Logan (HSE).

Item 1: Welcome

Professor David Harrison opened the meeting explaining that he would be chairing today, as Professor Gore was unable to attend. The Chair welcomed the Committee to its 62nd meeting.

Item 2: Minutes of the 61st meeting of GTAC

The minutes were agreed as an accurate and true record of the 61st 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 130: A phase I study to assess the safety and immunogenicity of new TB vaccine candidates FP85A and MVA85A, in healthy adults who have previously been immunized with BCG, using a prime boost

Tuberculosis (TB) is an airborne disease with increasing numbers of infections worldwide. The study is designed for healthy volunteers to investigate two possible TB vaccines, a recombinant fowl pox virus and a recombinant modified vaccinia ankara virus. Both vectors contain the same antigen, namely Mycobacterium Tuberculosis (M.tb) antigen 85A. The Committee had seen the MVA vector before in GTAC 118.

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

iItem 6: Annual Report

The Secretariat provided a draft of the GTAC annual report for 2006. The Committee was content.

Item 7: SUSAR Update

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

item 8: New Protocol GTAC 129. An ascending dose trial of the safety, tolerability and biological effect of intra-arterial injection of the selectively replication-competent herpes simplex virus HSV1716 in patients with unresectable hepatocellular carcinoma

The Chair, Professor David Harrison declared an interest in this protocol and left the room. Mr Michael Harrison the alternate vice Chair chaired this session.

This was the fifth protocol the Committee has seen using the HSV1716 vector (GTAC 18, GTAC 18A, GTAC 18B (all for glioma), GTAC 26 (metastatic melanoma), GTAC 50 (head and neck cancer) and GTAC 74 (glioblastoma).

The Committee had a short discussion on this protocol The Committee gave approval for this trial.

The Chair, Professor David Harrison returned to the chair.

Item 9: New Protocol GTAC 131: A phase I/II trial to compare the immunogenicity and safety of 3 DNA C prime followed by 1 NYVAC C boost to 2 DNA C prime follows by 2 NYVAC C boost.

This submission was based on two previous trials (GTAC 075 and GTAC 085). There are two vectors: NYVAC C, an MVA derived vector, and a HIV-1 DNA C plasmid vaccine.

The Committee had a short discussion on this protocol The Committee gave approval for this trial.

Item 10: Any Other Business

Update on the TG1412 incident

The Secretariat informed the Committee that the MHRA has now formalised a new application procedure for first-in-man studies of certain "higher risk" molecules. A new Expert Advisory Group (EAG) to MHRA is being set up to advise MHRA on such trials.

Substantial amendment: GTAC 127: A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010 (MVA-MUC1-IL2) as an Adjunct to Standard Chemotherapy in Advanced Non Small Call Lung Cancer (lung cancer)

The Secretariat had received an application for substantial amendment to GTAC 127. The requested changes a request to turn this phase IIb trial into a phase III. The new title will be: A Phase III multicentric controlled study evaluating the therapeutic vaccine TG4010 (MVA-MUC1-IL2) as an adjunct to standard chemotherapy in advanced Non Small Cell Lung Cancer.

The Committee were content and approved the amendment.

Public meeting

The Secretariat drew members attention to the draft programme for the GTAC public meeting 2007 which will be aimed at 6th formers and GCSE students.

Item 11: Press Cuttings

There was no discussion of the press cuttings.

AFTERNOON: Review of the flagging project, see separate note.

NEXT MEETING: Wednesday, 2 May 2007, Wellington House

GTAC Secretariat
March 2007

Top

copyright: © | last updated 27 March 2007