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