Participating in an HIV vaccine trial
By Jo Robinson, London, UK
A participant’s 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
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. Mary’s 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.
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 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.
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.