HIV Vaccine Clinical Trials

1. HIV Vaccine Clinical Trials The need for community involvement

2. My involvement in vaccines • I am currently working for Imperial College at St. Mary’s Hospital, London as HIV Research Manager • At the Clinical Trials Centre we have completed 3 HIV vaccine trials and about to recruit to 4th • All trials so far have been in low-risk healthy volunteers • At some point in the future we hope to carry-out some large scale, “high risk” group trials

3. What is the community? • What do we mean by the community? • General population? • Local population? • The elected governments? • Non governmental organisations? • HIV positive groups? • HIV positive individuals? • At risk HIV negative population, groups and individuals?

4. The Community in Phase I trials • All are involved in some way in the development of an HIV vaccine • The government must be involved by funding/promoting HIV vaccine development • The general population/individuals are involved by volunteering for trials • The NGOs must be involved by reviewing the trials and publicising them • HIV infected individuals and high risk groups currently are the least involved

5. Community involvement in past vaccine trials • Community involvement has nearly all been through the HIV NGOs • their involvement has increased with each new trial. • They have the knowledge to assess the validity of the work. • Their endorsement gives the trials credibility within the HIV community. • Promoting the vaccine trials within the HIV community and the media helps with recruitment.

6. NGO involvement • On a recent vaccine trial 10% of volunteers were recruited through HIV newsletters and 20% via e-mails sent around staff at NGOs • NGOs have given advice to possible volunteers about participating in an HIV vaccine trial • Representatives from NGOs & patient groups have attended pre-launch meetings for vaccine trials

7. Phase III HIV vaccine trials • Phase III trials assess the efficacy and safety in large numbers of “high risk” population • Phase III vaccine trials will need to recruit between 3,000 and 15,000 people to be statistically powered to prove the vaccine is able to prevent HIV infection • In order to recruit this many volunteers many months of preparation work and promotion will be needed whether the trials are in the UK or worldwide

8. AIDSVAX trials • Only two Phase III HIV vaccine trials have been completed • Results from both were reported earlier this year • The first was in 5000 gay men and 400 women and was conducted in the USA, Canada, Puerto Rico and the Netherlands • The second in 2500 injecting drug users in Thailand • Neither trial was able to show that the vaccine prevented HIV infection

9. Future plans • As part of the preparation for future phase III trials we will set up a Community Advisory Board. • Information from the CAB will help develop trial strategies • The board will include representatives from the local community, gay community, members of NGOs, public health officials and people living with HIV • Main target group for the trials will probably be the gay community

10. What need to be done? • Further development of our collaborations with the NGOs. • Carry out some social research with them which can be developed at the same time as the trial protocols • Introduce a participant advisory group to learn from the people who have actually taken part in a trial

11. Thoughts for future trials • Are there any other ways we can increase the input of the HIV community and at risk groups in the planning and promotion of future phase I/II & phase III trials? • Is it really necessary if there may never be a phase III trial in the UK? • And finally…….

12. Advertisement • We need healthy volunteers for EUROVAC II a phase I trial of an HIV vaccine. • If you would like to help please call Miranda Cowen at the Clinical Trials Centre, St. Mary’s Hospital, Paddington on free-phone 0800 587 4406 • Thank you