987654321

How Can We Overcome Obstacles

to an AIDS Vaccine?

AIDS VACCINE ADVOCACY COALITION

MAY 2000

YEARSANDCOUNTING...

C1

Years and Counting:

7

5

4

3

2

1

CAN A SHIFTING LANDSCAPE ACCELERATE AN AIDS VACCINE?

AIDS VACCINE ADVOCACY COALITION — MAY 2001

Y E A R S & C O U N T I N G

HOW DO YOU FIGHT A DISEASE

OF MASS DESTRUCTIONAND OTHER QUESTIONS ON THE ROAD TO AN AIDS VACCINE.

?. . .

VIII VII VI IV III II I

Years & Counting

AVAC AIDS VACCINE ADVOCACY COALITION ‒ MAY 2oo2

SCIENCE, URGENCY, AND COURAGEVRWANDA

KENYA

MALAWI

TANZANIA

BOTSWANA

SOUTH AFRICA

HAITI

UNITED KINGDOM

BELGIUM

FRANCE SWITZERLAND

GERMANYNETHERLANDS

RUSSIA

FINLAND

ITALY

UNITED STATES

CANADA

PERU

UGANDA

THAILAND

AUSTRALIA

ZAMBIA

CHINA

INDIA

BRAZIL

A I D S VA C C I N E T R I A L S — G E T T I N G T H E G L O B A L H O U S E I N O R D E R

CAMEROON

U.S./PUERTO RICO

TRINIDAD & TOBAGO

DOMINICAN REPUBLIC

JAMAICA

AVAC REPO RT 2 0 0 4

AIDS VACCINES AT THE CROSSROADS

AVACAID

SVAC

CIN

EAD

VOC

ACY

CO

ALIT

ION

20

05

AIDS Vaccines: The Next Frontiers

AVAC Report

20

06

R E S E T T I N GT H E C L O C K

Piecing Together theHIV Prevention Puzzle

AVAC Report 2009

R e p o r t 2 0 1 0

T U R N I N G

T H E

PA G E

THEEND

R E P O R T 2 0 1 2

ACHIEVINGTHE END

One Yearand

Counting

www.avac .o rg

AVAC REPORT 2013 : Research & Reality

PREVENTIONon the Line

AVAC Report 2014/15

December 2015

199219881987 1993 1994

International Community of Women Living with HIV/AIDS founded First phase II AIDS vaccine trial begins, of two gp120 products

First US government trial held of preventive vaccine candidate The AIDS Service Organization (TASO) established in Uganda

Female condom receives approval from US FDAUS Congress requires NIH and other agencies to expand involvement of women and minorities in all research

First major syringe exchange program opens in the US

US Public Health Service recommends AZT for pregnant women with HIV to reduce onward transmission

AIDS VACCINES, HIV PREVENTION AND THE GLOBAL EPIDEMIC: A TIMELINE

When AVAC was founded in 1995, we were called the

AIDS Vaccine Advocacy Coalition. Our singular goal

was to advance swift, ethical research for a vaccine

that was then—and is today—essential to bring the

epidemic to a conclusive end.

Twenty years later, AVAC is still focused on swift and

ethical research, but our scope has expanded. Along

with vaccines, we advocate for PrEP, microbicides,

voluntary medical male circumcision, and more.

And we’ve evolved with the field. As positive results

have delivered new tools, AVAC has led the charge

for the rapid, strategic rollout of all options needed

to end the epidemic.

Through it all, our message has been the same: prevention is the center of the AIDS response. Not just any prevention but smart, evidence-based, community-owned, rights-based strategies.

AVAC is the only advocacy group working across the full spectrum of biomedical prevention interventions, from early-stage research to large-scale rollout.

We do this work because it’s essential. We are able to do it because of our robust partnerships worldwide. We will keep doing it—with your help—until the epidemic has, finally, come to an end.

T W O D E C A D E S , O N E M E S S A G E : P R E V E N T I O N M AT T E R S

1995

The first protease inhibitor approved; effective HIV treatment now exists. AVAC co-founder Bill Snow publishes, Why We Need AIDS Vaccine Activism; AVAC founded the next month

K E E P I N G T H E F I E L D O N T R A C K —N O M AT T E R W H AT.

We’ve experienced 20 years of breakthroughs and disappointments in prevention research. A vaccine that many had given up on was the first to provide modest protection. One microbicide everyone hoped for didn’t pan out. Male circumcision and PrEP studies overcame skepticism and, together with antiretroviral therapy, paved the way for a prevention revolution. Through it all, AVAC has worked with partners to maintain the field’s focus and press for continued research into an AIDS vaccine, a cure and more.

1996

UNAIDS formed Levine Committee calls for overhaul of NIH AIDS research International AIDS Vaccine Initiative (IAVI) formed

1997

US President Bill Clinton announces goal of effective AIDS vaccine in 10 years UNAIDS estimates 16,000 new HIV transmissions each day

1998

First efficacy trials of VaxGen’s AIDSVAX candidate start South Africa’s Treatment Action Campaign founded

1999

South African AIDS Vaccine Initiative (SAAVI) establishedFirst African AIDS vaccine trial begins in Uganda

Ending the AIDSepidemic takescomprehensive

targets and action.

Vaccine

Diag

nose

d

On Tr

eatm

ent

PrEPCombinationPrevention Microbicides

Voluntary

Medical M

ale

Circumcision

Safe

, Effe

ctive

Cont

race

ptive

Met

hods

Cure

Human

RightsSyringeExchange

HarmReduction

Virally

Suppressed

Dx

U

2000 2001 20032002

Dale and Betty Bumpers Vaccine Research Center (VRC) opened at NIH Thousands march for global treatment access in Durban, South Africa

Eastern Europe and former Soviet Union reported to have highest rising rates of new infections in the world UN General Assembly convenes first ever special session on AIDS

George W. Bush announces PEPFAR initiativeRationale for Global HIV Vaccine Enterprise laid out in Science

IAVI, VRC and other leading laboratories and collaborators form Neutralizing Antibody Consortium—first entity of its kind dedicated to solving this key scientific challenge facing field

D E F I N I N G T H E P AT H F R O M R E S E A R C H T O R O L L O U T.

When AVAC was founded, the only biomedical HIV prevention options for adults were male and female condoms. The pathway for introducing any new strategy was largely unmapped. No one knew where the gaps would be—between trial result and country action, between guidance and financial support. Now we do. Over two decades, AVAC has not only identified the gaps; we’ve worked to bridge them, so that products reach people in programs that work—without delay.

Research to Rollout: A schematic road map

Phase III

Phase II/IIb

Phase I

ScaleUp

Product Introduction

Demonstration Projects

Open-Label Extension / Post-Trial

Access

Clinical Trial Safety and Efficacy

Real-World Effectiveness

For the first decade of AVAC’s existence, most prevention advocacy focused on actions to the left of the red arrow above. But with results, come new challenges. We now work on research and on ensuring products cross the gap between efficacy and real-world use.

Merck and HIV Vaccine Trials Network launch “test of concept” study of adenovirus-based vaccine Global HIV Vaccine Enterprise Scientific Strategic Plan published in PLoS Medicine

2004 2005 2006 2007

Bill and Melinda Gates Foundation announces $287 million to support the Collaboration for AIDS Vaccine Discovery (CAVD) Kenyan and Ugandan trials confirm South African data showing voluntary medical male circumcision reduces HIV risk for HIV-negative men US FDA announces approval of Gardasil™, which protects against strains of HPV that cause cervical cancer

Step and Phambili trials halted—Merck’s MRK-Ad5 vaccine shows no benefit and increased susceptibilty among some volunteersWHO recommends voluntary medical male circumcision for HIV prevention

Protests at Bangkok AIDS Conference target PrEP trials VaxGen Thai trial shows no efficacyMalawian government halts PrEP trial citing concerns about using ARVs for prevention

2008

NIH convenes summit on HIV vaccine research with renewed emphasis on basic research

C R E AT I N G A G L O B A L N E T W O R K O F P R E V E N T I O N A D V O C AT E S .

Twenty years ago, advocacy for HIV prevention hardly existed. So AVAC helped build a global network of advocates equipped with effective advocacy strategies and the latest evidence. With our support, they are putting prevention on the agenda in countries and communities around the globe.

Partnering for a Prevention Revolution

Through Advocacy Fellows, PxROAR members, coalition-building, strategic convening, training and other support, AVAC partners with stakeholders throughout the world to increase awareness and understanding of the current state of HIV prevention research and implementation. Together, we hold decision-makers accountable and press for smart investments and sound policies in all aspects of HIV prevention.

2008 2009 2010 2011

RV144 trial of ALVAC/AIDSVAX shows modest 31.2% efficacy in preventing HIV acquisition—first evidence of efficacy in any AIDS vaccine clinical trialHVTN 505 trial of DNA prime/Ad5-boost vaccine beginsSouth Africa begins massive expansion of ART program

HPTN 052 trial shows treatment can reduce risk of transmission by up to 96%Partners PrEP trial shows high efficacy of daily oral PrEP in HIV-negative men and women in serodiscordant couples

CAPRISA 004 trial of Tenofovir gel shows modest efficacy in South African women— a first for microbicidesiPrEx trial shows efficacy of dail oral PrEP in gay men and transgender womenPox Protein Public-Private Partnership (P5) established to build on results of RV144

US FDA approves daily Truvada as oral PrEP Analysis of RV144 results reveals two correlates of risk in participantsHundreds of broadly neutralizing antibodies IDed as possible targets for vaccine development

2012

D E M A N D I N G A C T I O N O N A N A G E N D A T O E N D A I D S .

When the world lacked a plan for ending AIDS, we helped create one. Now we’re holding global leaders accountable for results—demanding the resources, policies and evidence-based plans needed to deliver all of today’s prevention options to the people who need them, and to plan for the rapid rollout of new options as they emerge.

A Three-Part Agenda for Ending AIDS

DEMONSTRATE and roll out new HIV prevention options

DEVELOP long-term solutions needed to end the epidemic

DELIVER proven tools for immediate impact

Years to impact Zero to 5 5 to 10 10 to

CO

MB

IN

E

GOAL: A sustained decline in

HIV infections

End

2013 2014 2015

P5 outlines two proposed vaccine licensure trials—one in Thailand and the other in South Africa—and an additional research trial in Southern AfricaHVTN 505 stops immunizations after DSMB finds trial cannot show efficacy

Annual AIDS Vaccine Conference and biennial Microbicide Conference merge to become the HIV Research for Prevention Conference (HIV R4P), the first biomedical HIV prevention conference UNAIDS announces new 90-90-90 goal for testing, treating and viral suppression; prevention and non-discrimination goals developed but not launched

START trial stopped early, confirms individual health benefits of starting those living with HIV on antiretroviral therapy ART at CD4 cell counts above 350WHO releases new recommendations: 1) Initiation of ART in all people living with HIV, regardless of CD4 cell count, and 2) Offer of PrEP as a prevention option to all people at substantial risk of acquiring HIV

ECHO trial to explore possible link between hormonal contraception and HIV acquisitionFACTS 001 trial does not demonstrate efficacy of 1% tenofovir microbicide gelTwo phase II trials of different long-acting injectable ARVs launched

M A N A G I N G T H R O U G HC O N T R O V E R S Y.

Communities’ support for prevention research can never be taken for granted—it has to be earned. For 20 years, we’ve helped build trust between researchers, funders and communities to speed the ethical development and rollout of new prevention options. And when controversy threatened to derail those efforts, AVAC provided leadership and resources to help get them back on track.

The Good Participatory Practice (GPP) Guidelines provide trial funders, sponsors and implementers with systematic guidance on how to effectively engage with all stakeholders in the design and conduct of biomedical HIV prevention trials.

Your gift to AVAC will support our efforts to accelerate the

development and delivery of HIV prevention options to men

and women worldwide. With your help, we can continue to

convene, collaborate and communicate a strong, clear and

cohesive vision for HIV prevention today, tomorrow and to

end the epidemic.

It will take all of us working together to end AIDS.

Please join us.

To learn more about AVAC, including our history, our focus

and our team, please visit www.avac.org. And to support this

work, please go to www.avac.org/donate.

S U P P O R T I N G O U R W O R K

423 West 127th Street4th floorNew York, NY 10027USA

T +1 212 796 6423F +1 646 365 3452E avac@avac.orgW www.avac.org

FOLLOW US ONLINE

www.facebook.com/hivpxresearch

www.avac.org

www.youtube.com/hivpxresearch

www.twitter.com/hivpxresearch

Achieving theEnd of AIDSThe world is talking about ending AIDS. AVAC’s advocacy is dedicated to realizing that vision. To get there we must:

• Deliver proven tools for immediate impact.

• Demonstrate and roll out new HIV prevention tools.

• Develop long-term solutions to end the epidemic.