1. Participating in an HIV vaccine trial By Jo Robinson, London, UK

2. A participant’s perspective ä Trial characteristics ä Am I a typical participant? ä Beginning – informed consent ä The jabs ä The middle stage – clinic experiences ä Things start to go wrong ä Pressure and thoughts about withdrawing consent ä Coming full circle – the future

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

4. Am I a typical volunteer? ä Sex: Female (All volunteers: 55% female, 45% male) ä Age: 29 (Mean age: 35) ä Current sexual partner: (All volunteers: 61%) ä Employed/Student: (All volunteers: 97%) ä Sexuality: Gay (All volunteers: 22% gay) ä Main motivation: Altruism (All volunteers 44%) ä Link with HIV: Family & friends affected (All volunteers: 30%) ä Interest in subject: (All volunteers: 32%)

5. Beginning – informed consent ä Jargon: They say: A randomised double blind placebo controlled trial ä We say: No one knows what’s going on ä 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 ä We say: I’m bored and it’s annoying how many questions I have to answer about my sex life ä Raised liver enzymes – further tests, no payment ä Enrolment – blood tests ä More blood tests, and more… ä No payment for first four visits as nurse has not been to the bank (again) ä A set of blood tests from a stranger who then turned out to be Ken

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

7. My (work) life ä I start to have health problems and clinic healthcare is better than my GP. I start to ask are these problems vaccine related? ä Being part of a small group of HIV NGOs invited to talk about vaccine trials – being told the trial you’re on won’t work (early) ä Press enquiries – talking as a participant as well as a worker ä Worrying well-meaning friends – HIV stigma ä Other healthcare workers – assumptions about HIV status from the GP, in the sexual health clinic etc. ä Cynicism hits the field (futility of volunteering becomes an issue) ä Trial data on hold again – the mice – finding out by mistake from IAVI

8. Coming full circle – moving on ä Now widely acknowledged that if you participate once you probably can’t again (solves that dilemma!) ä Issues around whether using these early vaccines will mean you can’t benefit from one that might really work ä Lack of feedback mechanisms – no participant evaluation, no social research, no Community Advisory Board or other involvement techniques. ä DNA technologies dropped by IAVI. ä Forming a UKCAB sub-group on vaccines and microbicides and looking to the future.