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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Mitchell Warren AVAC 2 July 2013 IAS Symposia Session: HIV Vaccines and Future Strategies

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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


Where do we come from what are we where are we going

Where Do We Come From? What Are We? Where Are We Going?

Paul Gauguin, 1897


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.


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