Oral Abstract Session 01 - Global HIV Vaccine Enterprise

SYMPOSIA SESSIONS
38
Symposia Sessions
Symposium 04: Cross-cutting Issues in Clinical Trial Design
S04.01
PrEP and Vaccines: When and How to Respond to
Positive Data
M Warren 1
1 AVAC, New York, NY, USA
Good news can bring tough questions. As biomedical prevention
trials demonstrate effectiveness, there is intense attention on the
gap between the end of the trial and the next step to access—
especially necessary implementation research and access for
participants in the original study that provided positive results. In
particular, recent positive results from the HPTN 052 “treatment
as prevention” trial and a range of pre-exposure prophylaxis trials
(PrEP) have transformed the HIV prevention field. In addition to
possible public health implications of delivery, these results also
raise important questions about the implications for how these
results will influence HIV prevention trials in the future.
This presentation will review the current state of the field;
present some of the critical issues that need to be considered by
researchers, advocates, trial designers, program implementers
and policy makers; and explore how the AIDS vaccine field might
adapt to emerging results from PrEP and other biomedical
prevention trials and responding to positive data with new ideas
for trial design and combination prevention. In particular, this
presentation will outline some of the critical issues related to the
recent US FDA approval of PrEP, WHO guidance and how ongoing
and future trials might respond to it.
Vaccine researchers and advocates need to explain and rally
support for the continued search for a preventive vaccine, within
the context of these other scientific advances. As PrEP and other
prevention strategies are introduced, the niche that a partially
effective vaccine might fill can become better defined in terms
of geography, route of exposure, background combination
package and so on, but the AIDS vaccine field will need to take
the initiative in bringing this into focus.
AIDS Vaccine 2012
S04.02
Evolving Standards of Prevention and Implications
for Future Trials
D.R. Wassenaar 1
1 SARETI, UKZN, Pietermaritzburg, South Africa
This presentation will discuss selected ethical issues charcterising
the current HIV prevention landscape with particular
reference to implications for standard of prevention in current
and future HIV prevention trials. These issues will be discussed
against a background of other general ethical issues in HIV prevention
research.