Participating in an HIV vaccine trial

By Jo Robinson, London, UK

A participant’s perspective

Trial characteristicsAm I a typical participant?Beginning – informed consentThe jabsThe middle stage – clinic experiencesThings start to go wrongPressure and thoughts about withdrawing consentComing full circle – the future

Trial characteristics

A participants’ perspective:Part of a group of 120 –twinned with KenyaClade C DNA + MVA prime boost approachTrial visits at St. Mary’s Hospital, London, UKResults announced August 2004 shown to have poor

un-sustained immunological results IAVI decided to halt work on its DNA technologiesUn-blinded October 2004 – I was given 0.5mg DNA

(low dose) plus MVA.

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%)

Beginning – informed consent

Jargon: They say: A randomised double blind placebo controlled trial

We say: No one knows what’s 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: I’m bored and it’s 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

My mind goes to work on the jabs

The jabs – they hurt, and cause big red marksTesting and monitoring – more visitsStarting 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 consentFeeling pressurised (by myself) not to withdraw.

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 you’re on won’t 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

Coming full circle – moving on

Now widely acknowledged that if you participate once you probably can’t again (solves that dilemma!)

Issues around whether using these early vaccines will mean you can’t 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.