Telling time telling the truth engaging communities as stakeholders and partners in hiv vaccine r d
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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.

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Telling time telling the truth engaging communities as stakeholders and partners in hiv vaccine r d

Telling Time; Telling the TruthEngaging communities as stakeholders (and partners) in HIV vaccine R&D

Mitchell Warren

AVAC

2 July 2013

IAS Symposia Session: HIV Vaccines and Future Strategies



Mitchell warren avac 2 july 2013 ias symposia session hiv vaccines and future strategies

HIV Prevention Options Timeline July 2013 ***

Bangkok Tenofovir Study/CDC 4370

2005

Oral TDF

TIMELINE LEGEND

Oral TDF

Partners PrEP

Partners PrEP (no placebo)

Oral TDF/FTC

2008

Positive efficacy result

TFV gel

2009

VOICE/MTN 003

No effect

Rectal TFV gel

Oral TDF/FTC

Regulatory submission/filing

TDF2/CDC 4940

TDF2 Open-Label Extension

DPV ring

2007

TMC278 LA Injectable

iPrEx

iPrEx Open-Label Extension (OLE)

2007

Planned

FEM-PrEP

DNA/Ad5

2009

Final results pending

Additional demonstration projects & intermittent PrEP studies

Pox-Protein

US FDA approval

CAPRISA 004

2007

TFV gel

CAPRISA 008

VOICE/MTN 003

Earliest regulatory submission

2009

FACTS 001

Rectal TFV gel

FACTS 002 and other adolescent studies

DPV Ring

MTN 017

Earliest regulatory submission

ASPIRE/MTN 020

TMC 278 LA Inject.

The Ring Study/IPM 027

Various Phases of Long-Acting Injectables

Possible LA Injectables

HVTN 505

DNA/Ad5

2009

South Africa Licensure

RV 144

Pox-Protein

2004

South Africa Research

Various Phase I/II preliminary and bridging studies

Thai Licensure

* 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.

AVAC Report 2012: Achieving the End – One year and counting. www.avac.org/report2012


What we said after step in 20 07
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
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

    • No matter what the headlines say, a single number is not the full result

  • No one trial answers all the questions

    • Just as no one product or approach is “the” answer for AIDS vaccines

    • Just as an AIDS vaccine is not “the” answer to ending the epidemic

  • It’s all incremental – no magic bullets


Where to from here
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
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
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.


Mitchell warren avac 2 july 2013 ias symposia session hiv vaccines and future strategies

Now what?

  • Ensure preparedness efforts for “P5” trials are on track in Southern Africa and Thailand

    • Stakeholder dialogues; ongoing coordination with P5 partners; GPP work at proposed site levels

    • 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

    • Broader “ending AIDS” advocacy

    • Therapeutic vaccine and cure agendas and advocacy


Three part agenda for ending aids
Three-Part Agenda for Ending AIDS

Deliverproven tools for immediate impact

  • Testing

  • Treatment

  • Voluntary Medical Male Circumcision

  • Female and male condoms

  • Prevention of pediatric infection

  • Syringe exchange programs

  • End confusion about “combination prevention”

  • Narrow gaps in treatment cascade

  • Prepare for new non-surgical male circumcision devices

GOAL: A sustained decline in HIV infections (now at 2.5 million/year)

Demonstrateproven tools for immediate impact

  • Define and initiate the “core package” of PrEP demonstration projects

  • Daily oral TDF/FTC as PrEP

  • 1% tenofovir gel

COMBINE

Developlong-term solutions to end the epidemic

  • AIDS vaccines

  • Cure

  • Multi-purpose prevention technologies

  • Next generation ARV-based prevention

  • Non-ARV-based microbicides

  • Rectal microbicides

  • Safeguard HIV Prevention Research Funding

Years to Impact

End

5 to 10

Zero to 5

10 to

AVAC Report 2012: Achieving the End – One year and counting. www.avac.org/report2012.