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Telling Time; Telling the Truth Engaging communities as stakeholders (and partners) in HIV vaccine R&D. Mitchell Warren AVAC 2 July 2013 IAS Symposia Session: HIV Vaccines and Future Strategies. Where Do We Come From? What Are We? Where Are We Going?. Paul Gauguin, 1897. - PowerPoint PPT Presentation
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Telling Time; Telling the TruthEngaging communities as stakeholders
(and partners) in HIV vaccine R&D
Mitchell WarrenAVAC2 July 2013IAS Symposia Session: HIV Vaccines and Future Strategies
Where Do We Come From? What Are We? Where Are We Going?
Paul Gauguin, 1897
DNA/
Ad5
2010 2011 2012 2013 2014 2015 2016
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
Positive efficacy result
No effect
Regulatory submission/filing
Planned
Final results pending
DPV ring
Oral TDF/FTC
Oral TDF
Rectal TFV gel
TFV gel
TMC278 LA Injectable
DNA/Ad5
TIMELINE LEGEND
Pox-Protein
HIV Prevention Options Timeline July 2013 * **
* Trial end-dates are estimates; due to the nature of clinical trials the actual dates may change. For full trial details, see www.avac.org/pxrd. ** Not all trials included are effectiveness trials. Trials included on this list are mainly phase II/IIb, III/IIIb and IV trials.
Bangkok Tenofovir Study/CDC 4370
Partners PrEP Partners PrEP (no placebo)2008
2005
2009 VOICE/MTN 003
Ora
l TDF
/FTC
Ora
l TDF
iPrEx2007 iPrEx Open-Label Extension (OLE)
2009 FEM-PrEP
US FDA approvalCAPRISA 0042007
2007 TDF2 Open-Label ExtensionTDF2/CDC 4940
TFV
gel
FACTS 001Earliest regulatory submission
VOICE/MTN 0032009
MTN 017
Rect
al T
FV
gel
DPV
Ring
The Ring Study/IPM 027
ASPIRE/MTN 020
Earliest regulatory submission
Possible LA Injectables
TMC
278
LA
Inje
ct.
Pox-
Prot
ein
Various Phase I/II preliminary and bridging studiesRV 1442004
South Africa Licensure
South Africa Research
Thai Licensure
2009 HVTN 505
Additional demonstration projects & intermittent PrEP studies
CAPRISA 008
FACTS 002 and other adolescent studies
Various Phases of Long-Acting Injectables
AVAC Report 2012: Achieving the End – One year and counting. www.avac.org/report2012
What We Said After Step in 2007*
* ...and after RV144 in 2009; 505 and Phambili in 2013R&D is an iterative processEvery trial teaches us somethingWe need a wider variety of approaches in the pipelineVaccines take a long time to developSamples from the trial are a precious resource to help
explain what happened with the vaccineThe field must take a deep breath, a step back and
assess the implicationsProceed with discovery work that includes human clinical
trials
What’s Past is Prologue
Large efficacy trials are possible and essential – and complex and unpredictable
It’s not the result as much as what we do with ito No matter what the headlines say, a single
number is not the full resultNo one trial answers all the questionso Just as no one product or approach is “the”
answer for AIDS vaccineso Just as an AIDS vaccine is not “the” answer to
ending the epidemic It’s all incremental – no magic bullets
Where to from here
Mine trial data in every way possible, using the limited trial samples strategically and wisely
Continue the upstream scientific focus to develop better candidates that can build on current knowledge, fill gaps and get into trials
Think harder about new trial designsDeliver what we have today for prevention & treatment
AIDS Vaccines 2013 and beyond
P5 – Pox-Protein Public-Private PartnershipOther products currently in clinical development Replicating vectors Translating NAb discoveries into vaccine
candidatesPassive immunization and gene therapy studiesAnd how to engage a variety of communities and
stakeholders in the inevitable ups and downs and uncertainties
What is “stakeholder engagement?”
Stakeholder engagement is not recruitment! (Recruitment is recruitment…)
It is a process of using the expertise stakeholders have to improve the research process and shape it together
It requires/benefits from improved research literacy amongst all stakeholders
Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials, UNAIDS & AVAC, 2011, www.avac.org/gpp.
Now what? Ensure preparedness efforts for “P5” trials are on track in Southern Africa
and Thailand o Stakeholder dialogues; ongoing coordination with P5 partners; GPP
work at proposed site levelso Publications and communications that address “what next”, “why so
long” and clarity of changing timelines Work to consensus on appropriate standard of care and prevention in
proposed trials including P5, passive immunization trials and others Sharpen and sustain messages about need for continued funding, state of
the science and pipeline, and essential role of vaccine in long-term success at “ending AIDS”
Connect preventive vaccine agenda and advocacy witho Broader “ending AIDS” advocacyo Therapeutic vaccine and cure agendas and advocacy
CO
MB
IN
E
Demonstrate proven tools for immediate impact
• Daily oral TDF/FTC as PrEP• 1% tenofovir gel
Develop long-term solutions to end the epidemic• AIDS vaccines• Cure• Multi-purpose prevention technologies• Next generation ARV-based prevention• Non-ARV-based microbicides• Rectal microbicides
Years to Impact Zero to 5 5 to 10 10 to End
GOAL: A sustained d e c l i n e i n H I V infections (now at 2.5 million/year)
• Define and initiate the “core package” of PrEP demonstration projects
• Safeguard HIV Prevention Research Funding
• End confusion about “combination prevention”
• Narrow gaps in treatment cascade• Prepare for new non-surgical male
circumcision devices
• Testing• Treatment• Voluntary Medical Male Circumcision • Female and male condoms• Prevention of pediatric infection• Syringe exchange programs
Deliver proven tools for immediate impact
AVAC Report 2012: Achieving the End – One year and counting. www.avac.org/report2012.
Three-Part Agenda for Ending AIDS