HIV Vaccine Clinical Trials

The need for community involvement

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

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?

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

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.

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

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

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

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

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

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…….

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