Presentation on theme: "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:"— Presentation transcript:
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
DNA/Ad5 2010201120122013201420152016 1 234123412341234123412341234 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 Oral TDF/FTC Oral TDF iPrEx 2007 iPrEx Open-Label Extension (OLE) 2009 FEM-PrEP US FDA approval CAPRISA 004 2007 TDF2 Open-Label Extension TDF2/CDC 4940 TFV gel FACTS 001 Earliest regulatory submission VOICE/MTN 003 2009 MTN 017 Rectal TFV gel DPV Ring The Ring Study/IPM 027 ASPIRE/MTN 020 Earliest regulatory submission Possible LA Injectables TMC 278 LA Inject. Pox-Protein Various Phase I/II preliminary and bridging studies RV 144 2004 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 2013 R&D is an iterative process Every trial teaches us something We need a wider variety of approaches in the pipeline Vaccines take a long time to develop Samples from the trial are a precious resource to help explain what happened with the vaccine The field must take a deep breath, a step back and assess the implications Proceed 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 it o No matter what the headlines say, a single number is not the full result No one trial answers all the questions o Just as no one product or approach is “the” answer for AIDS vaccines o 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 designs Deliver what we have today for prevention & treatment
AIDS Vaccines 2013 and beyond P5 – Pox-Protein Public-Private Partnership Other products currently in clinical development Replicating vectors Translating NAb discoveries into vaccine candidates Passive immunization and gene therapy studies And 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 levels o 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 with o Broader “ending AIDS” advocacy o Therapeutic vaccine and cure agendas and advocacy
COMBINE 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 decline in HIV 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
Your consent to our cookies if you continue to use this website.