HIV Vaccine Clinical Trials

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HIV Vaccine Clinical Trials

• The need for community involvement

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My involvement in vaccines

• I am currently working for Imperial College at
  St. Marys 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

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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

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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

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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

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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

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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

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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.

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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. Marys
  Hospital, Paddington on free-phone [phone]
• Thank you