Participating in an HIV vaccine trial

1
Participating in an HIV vaccine trial

• By Jo Robinson, London, UK

2
A participants perspective

• Trial characteristics
• Am I a typical participant?
• Beginning informed consent
• The jabs
• The middle stage clinic experiences
• Things start to go wrong
• Pressure and thoughts about withdrawing consent
• Coming full circle the future

3
Trial characteristics

• A participants perspective
• Part of a group of 120 twinned with Kenya
• Clade C DNA MVA prime boost approach
• Trial visits at St. Marys Hospital, London, UK
• Results announced August 2004 shown to have poor
  un-sustained immunological results
• IAVI decided to halt work on its DNA technologies
• Un-blinded October 2004 I was given 0.5mg DNA
  (low dose) plus MVA.

4
Am I a typical volunteer?

• Sex Female (All volunteers 55 female, 45
  male)
• Age 29 (Mean age 35)
• Current sexual partner (All volunteers 61)
• Employed/Student (All volunteers 97)
• Sexuality Gay (All volunteers 22 gay)
• Main motivation Altruism (All volunteers 44)
• Link with HIV Family friends affected (All
  volunteers 30)
• Interest in subject (All volunteers 32)

5
Beginning informed consent

• Jargon They say A randomised double blind
  placebo controlled trial
• We say No one knows whats going on
• They say Fill in this form, and this one, and
  another 5 and we ask you to read back to us what
  is in your form so you understand
• We say Im bored and its annoying how many
  questions I have to answer about my sex life

• Raised liver enzymes further tests, no payment
• Enrolment blood tests
• More blood tests, and more
• No payment for first four visits as nurse has not
  been to the bank (again)
• A set of blood tests from a stranger who then
  turned out to be Ken

6
My mind goes to work on the jabs

• The jabs they hurt, and cause big red marks
• Testing and monitoring more visits
• Starting to really think about DNA and the
  delivery mechanism, - worrying about my own body
  can I trust this technology?
• The mice story pre-cancerous cells are
  discovered in mice in labs receiving MVA the
  trial is halted
• Feelings around withdrawing consent
• Feeling pressurised (by myself) not to withdraw.

7
My (work) life

• I start to have health problems and clinic
  healthcare is better than my GP. I start to ask
  are these problems vaccine related?
• Being part of a small group of HIV NGOs invited
  to talk about vaccine trials being told the
  trial youre on wont work (early)
• Press enquiries talking as a participant as
  well as a worker
• Worrying well-meaning friends HIV stigma
• Other healthcare workers assumptions about HIV
  status from the GP, in the sexual health clinic
  etc.
• Cynicism hits the field (futility of volunteering
  becomes an issue)
• Trial data on hold again the mice finding out
  by mistake from IAVI

8
Coming full circle moving on

• Now widely acknowledged that if you participate
  once you probably cant again (solves that
  dilemma!)
• Issues around whether using these early vaccines
  will mean you cant benefit from one that might
  really work
• Lack of feedback mechanisms no participant
  evaluation, no social research, no Community
  Advisory Board or other involvement techniques.
• DNA technologies dropped by IAVI.
• Forming a UKCAB sub-group on vaccines and
  microbicides and looking to the future.