iavi

The World Needs an
AIDS Vaccine

2013

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Our vision:
a world without AIDS

Our mission:
ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world

A Word from Our President & CEO

Margie McGlynn

We are at a critical juncture in AIDS vaccine research. An unprecedented flow of scientific breakthroughs and growing knowledge about HIV and the immune system are renewing energy and confidence. Researchers around the world are excitedly engaged in several new approaches. Yet while the epidemic continues to take an enormous toll on the lives of millions of people, particularly in the developing world, a misplaced perception that HIV/AIDS has become an easily managed disease makes it harder than ever to compete for increasingly constrained resources. Now is the time to raise our voices even more loudly to ensure the sustained support that will be needed to rid the world of AIDS once and for all.

In 2013, the AIDS vaccine field continued to advance multiple vaccine candidates, while making important discoveries that will guide the design of new approaches for the future. IAVI and our partners focused on advancing a few select, innovative approaches aimed at generating broad and long-lasting immunity against HIV. We learned a great deal more about targets on the surface of HIV for broadly neutralizing antibodies and advanced toward clinical development a first vaccine candidate to generate such antibodies. We commenced the first trial of an innovative approach in which a vector carries genetic instructions for an individual to produce their own broadly neutralizing antibodies. We completed enrollment of the first clinical trial of a novel replicating viral vector and moved others forward in preclinical studies. IAVI also expanded the Vaccine Product Development Center, supported by the Bill & Melinda Gates Foundation, providing services to help several of their grantees advance the development of promising vaccine candidates.

In 2013, the AIDS vaccine field continued to advance multiple vaccine candidates, while making important discoveries that will guide the design of new approaches for the future. IAVI and our partners focused on advancing a few select, innovative approaches aimed at generating broad and long-lasting immunity against HIV. We learned a great deal more about targets on the surface of HIV for broadly neutralizing antibodies and advanced toward clinical development a first vaccine candidate to generate such antibodies. We commenced the first trial of an innovative approach in which a vector carries genetic instructions for an individual to produce their own broadly neutralizing antibodies. We completed enrollment of the first clinical trial of a novel replicating viral vector and moved others forward in preclinical studies. IAVI also expanded the Vaccine Product Development Center, supported by the Bill & Melinda Gates Foundation, providing services to help several of their grantees advance the development of promising vaccine candidates.

IAVI continued to work with many partners in sub-Saharan Africa, the epicenter of HIV/AIDS, to learn more about the disease, conduct epidemiology studies and clinical trials, and support researchers, clinicians and advocates so that they can lead the fight to halt this epidemic that devastates their families and communities. In 2013, we trained scientists, clinicians and community outreach workers in five African countries; informed important policies at regional, national and international levels; and facilitated collaborations within Africa and beyond, such as between South Africa and India.

On behalf of our colleagues and partners working tirelessly toward an AIDS vaccine, I extend heartfelt thanks to the many donors whose steadfast support continues to inspire and empower us, and to the many supporters and volunteers whose dedication keeps us focused and moving forward.

Together, we will achieve a world without AIDS.

An AIDS Vaccine Will Be Transformative

IAVI Works Hand in Hand With the People Most Vulnerable to HIV/AIDS

In 2013, 2.1 million people contracted HIV and 1.5 million died of AIDS-related causes. More than half of the 35 million people living with HIV didn't know they were infected.

The vast majority of HIV cases occur in low- and middle-income countries where limited resources and infrastructure, as well as gender inequity, stigma and other societal issues, pose particular barriers for the people most at risk from HIV—including women, young people, men who have sex with men, sex workers, drug users, mobile communities and other marginalized groups.

Vaccines have proven extremely effective at preventing infectious diseases in a wide variety of geographic, economic and societal contexts. They can offer long-lasting protection that begins before a person is exposed to a virus, be distributed widely and confidentially within the context of broader public health and immunization programs, and reduce the burden of disease and healthcare utilization and spending.

The World Health Organization reports that up to half of new HIV infections occur among key groups least likely to get HIV prevention, testing and treatment services. In Uganda, for example, RESIDENTS OF FISHING COMMUNITIES are 4 times more likely to be HIV-positive than the general population.

WOMEN are biologically more vulnerable to HIV infection than men, and AIDS is the number one killer of women of reproductive age. In South Africa, for example, more than 1 in 10 young women between the ages of 15 and 24 live with HIV.

Approximately 4 million YOUNG PEOPLE aged 15-24 live with HIV, almost 3 million of them in sub-Saharan Africa. Moreover, 10.5 million CHILDREN in East and Southern Africa have lost one or both parents to HIV/AIDS.

MEN WHO HAVE SEX WITH MEN are 19 times more likely to be HIV-positive than the general population in low- and middle-income countries, and the only group with rising infections in most high-income countries.

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Michel Sidibé

Executive Director, UNAIDS

"IAVI's work is so important for us all. We must maintain the momentum in scientific research and development. A vaccine for HIV would offer hope to millions of people around the world. It will be needed, together with other new HIV prevention technologies, to end the AIDS epidemic and ensure that no one is left behind."

The Impact of an AIDS Vaccine

Adding an AIDS vaccine to existing treatment and prevention would dramatically reduce the global spread of HIV.

The following graphic shows how an AIDS vaccine could influence projected annual infections by 2050 at each of three levels of overall treatment and prevention coverage based on UNAIDS targets (one reflecting current trends and two additional scenarios reflecting enhancements).*

1.8m 535k Annual infections without a vaccine, if current trends in the response to HIV/AIDS continue Annual infections with a vaccine, if current trends in the response to HIV/AIDS continue 1.2m 366k Annual infections without a vaccine, assuming 50% progress toward UNAIDS recommendations for maximizing existing treatment and prevention Annual infections with a vaccine, assuming 50% progress toward UNAIDS recommendations for maximizing existing treatment and prevention 544k <185k Annual infections without a vaccine at full implementation of UNAIDS recommendations for maximizing existing treatment and prevention Annual infections with a vaccine at full implementation of UNAIDS recommendations for maximizing existing treatment and prevention

This graphic represents the potential impact of an AIDS vaccine as part of the UNAIDS Enhanced Investment Framework, IFE Modeling Project – UNAIDS, Futures Institute, IAVI, AVAC. This study is made possible by the generous support of the American people through the United States Agency for International Development (USAID). The contents are the responsibility of the International AIDS Vaccine Initiative and do not necessarily reflect the views of USAID or the United States Government.

*An illustrative vaccine with an assumed efficacy of 60%, not representative of any specific candidate in development. Coverage reaches 70% in generalized HIV/AIDS epidemics, 60% in concentrated epidemics.

How We Work

As a not-for-profit, globally operating Product Development Partnership (PDP), IAVI works with academic, government, industrial and NGO partners to connect innovative science with clinical development capabilities, translating laboratory breakthroughs into promising vaccine candidates.

IAVI conducts and supports AIDS vaccine discovery research focused on two key scientific challenges: understanding HIV's extensive global variability, and the need to provide broad and lasting immunity that addresses this variability. Our discovery work is closely integrated with our translational research capabilities, enabling IAVI to accelerate promising approaches into clinical testing. To date, we have helped to develop 26 AIDS vaccine candidates, advancing the most promising to clinical trials, including 15 trials in sub-Saharan Africa and India.

Our science, pursued with many partners, focuses on:

Discovery and development of vaccine candidates capable of eliciting broadly neutralizing antibodies (bNAbs) to prevent HIV infection;

Discovery and development of replicating viral vector-based vaccine candidates capable of preventing and controlling HIV infection; and

Providing product development services to the broader AIDS vaccine field to help advance the most promising candidates into clinical development.

IAVI catalyzes innovation through partnerships and investments such as our Neutralizing Antibody Consortium and its central hub at The Scripps Research Institute in La Jolla, California, and specialized laboratories in New York, New Delhi (a joint venture with the Government of India) and London (a partnership with Imperial College). We have extensive research and clinical partnerships with institutions in developing countries where the burden of HIV/AIDS is highest, such as Nairobi University and the Uganda Virus Research Institute—helping to inform scientific, epidemiological and policy research and analysis; ensuring that our efforts are focused where a vaccine is most needed; and strengthening sub-Saharan Africa's knowledge, skills and technology.

The IAVI community encompasses scientists, advocates, clinicians and community workers—on our staff, as well as many partners across the world.

Our alliances and programs in Africa increase the potential for greater African participation in more upstream AIDS vaccine research.

"I know firsthand the misery that HIV/AIDS causes among the men and especially the women of Africa. I am proud to put my scientific knowledge and skills toward finding a vaccine that can help erase this scourge forever."

Gaudensia Mutua, Scientist with the Kenya AIDS Vaccine Initiative, a collaboration of Nairobi University, the U.K. Medical Research Council and IAVI

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IAVI People

"We all aspire to successfully overpower the challenging foe that is HIV and return to a world free of AIDS."


Bimal Chakrabarti, New Delhi

"With our civil society partners, we communicate the need that translates into political and financial support."


Arwa Meijer, Amsterdam

"I am privileged to work alongside communities of people who most need a vaccine."


Leslie Nielssen, Entebbe

"Scientists and advocates must create a unified voice that makes the strongest case for an AIDS vaccine."


Prince Bahati, Nairobi

"IAVI is a responsible and transparent steward of the funds entrusted to us."


Patrick Mouton, New York

"Working with dedicated scientists across the world — together, we can do something amazing."


Jill Gilmour, London

2013 Highlights

In The Laboratory

IAVI scientists work around the world to accelerate the design of novel vaccine candidates, including at the HIV Vaccine Translational Research Laboratory, a partnership with the Government of India.

Advancing the Science

Since 2009, several potent broadly neutralizing antibodies (bNAbs) found through the landmark Protocol G study by members of our Neutralizing Antibody Consortium and other partners have neutralized a broad array of HIV variants in the laboratory and protected monkeys from a simian relative of HIV. In 2013, teams led by Cornell University and The Scripps Research Institute detailed the molecular structure of HIV's surface protein where these antibodies bind—an achievement that we and partners quickly began translating into a new vaccine candidate for clinical testing. In parallel, IAVI and partners discovered additional target sites using Protocol G antibodies. Meanwhile, working with the Children's Hospital of Philadelphia and the National Institute of Allergy & Infectious Diseases, we started the first clinical trial to see if a viral vector containing a bNAb gene can induce muscle cells to provide durable levels of antibodies.

IAVI is also assessing the potential of replicating viral vectors for strong and lasting prevention of HIV. Working with the Japanese biotech DNAVEC, we advanced a first candidate into a clinical trial with partners in Kenya, Rwanda and the United Kingdom, testing how a vaccine based on the Sendai virus and delivered intranasally might elicit cellular, antibody and mucosal immune responses. Replicating vectors based on the Canine Distemper and Vesicular Stomatitis viruses moved forward in preclinical studies, and the Vaccine Product Development Center helped partners from the Beth Israel Deaconess Medical Center and Oregon Health & Science University develop candidates based on the Adeno-26 and Cytomegaloviruses. As part of IAVI's work to achieve cellular immune responses to control HIV infection, we partnered with the University of Oxford to identify and test highly conserved HIV immunogens. A first candidate moved into the clinic in Oxford and we developed plans for trials in Africa in 2014.

Africa remains the focal point of IAVI's work to better understand the epidemic and enhance local vaccine research and development. In 2013, we and our partners continued epidemiological and observational studies to identify new bNAbs from Protocol G; gain novel insights into HIV's natural history from our Protocol C (the largest acute infection cohort in sub-Saharan Africa); track the epidemic among vulnerable populations via our Protocol B studies on HIV incidence; and prepare new cohorts for future efficacy trials. IAVI also facilitated extension of an AIDS vaccine design collaboration between the South African and Indian governments, and worked with the Indian Government to expand capacity at our joint HIV Vaccine Translational Research Laboratory in New Delhi, leading to discovery of a novel candidate based on the HIV strain that circulates in India.

Click here for the current portfolio

2013 Highlights

In The Community

IAVI and our partners foster many critical bridges between researchers and the communities in which they work.

Strengthening Conditions for a Vaccine

IAVI works with many partners to engender the relationships, supportive policies and infrastructure needed to develop an effective and accessible AIDS vaccine. This work happens on many levels—from community outreach that lays the groundwork for clinical trials, to training local doctors and researchers, to sharing evidence with regional, national and global decision-makers to keep AIDS vaccine research high on their agendas.

In 2013, IAVI and our partners worked with Community Advisory Board members in Kenya, Uganda, Rwanda, Zambia and South Africa to help them inform and represent their communities throughout the design and implementation of HIV prevention research projects—multi-year commitments that ensure that volunteers are heard and well served in all protocols and trials, including future AIDS vaccine trials. In Kenya, we helped develop a similar advisory mechanism for the national LGBT community and supported training of hundreds of clinicians to provide better health services to men who have sex with men, raising the level of care and lowering the barriers of fear and stigma that hinder HIV/AIDS research, prevention and treatment.

IAVI shares the knowledge generated through our research and development and community engagement activities to help inform and support regional and national decision-making in the countries hit hardest by HIV/AIDS. In 2013, IAVI contributed to Kenya's trail-blazing HIV Prevention Revolution Road Map, which prioritizes research into new prevention tools and lays important ground for future policy work in Kenya and beyond. In Uganda, IAVI helped convene government and international stakeholders to plan improved healthcare access for residents of Lake Victoria fishing communities—who account for most new HIV infections and live outside the reach of most services. In India, our work with the government helped expand community outreach, including the creation of the country's first rural HIV research center.

In the international arena in 2013, IAVI worked with civil society partners and other product development partnerships to include ambitious HIV/AIDS targets and support for global health R&D in the United Nations' initial outline of the Post-2015 Sustainable Development Goals. We will continue these efforts into 2015 until a final framework is agreed that will guide health, research and development agendas at the local, national and regional levels for the next 15 years.

Financial Snapshot

Revenue

Grants And Contributions
Government 43.9M
Private Sector Organizations/Individuals 14.5M
Investment Income & Other 1.9M
Total US$60.3M

Expenses

Program
Research & Development 46.9M
Advocacy, Policy & Communications 6.8M
Administration 6.9M
Fundraising 2.4M
Total US$63.0M

Assets

Assets
Cash & Investments 64.7M
Loans/Interest Receivables 16.0M
Grants Receivable 14.7M
Fixed Assets 15.6M
Other 1.4M
Total Assets US$112.4M

Liabilities 47.9M
Net assets 64.5M
TOTAL LIABILITIES & NET ASSETS US$112.4M
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FRANÇOISE BARRÉ‑SINOUSSI

Nobel laureate and Immediate Past President, International AIDS Society

"Achieving a world without AIDS will require greater access to prevention and treatment for all, the end of stigma and discrimination, and scientific progress to develop new therapeutic and preventative tools. Today HIV is pushing research for a cure and a vaccine onto entirely new—and increasingly common—ground, where researchers can learn a great deal from each other toward our common goal."

Where to Find IAVI & Our Partners

IAVI Offices & Laboratories

Global Headquarters and Design & Development Laboratory New York, USA

Neutralizing Antibody Center at The Scripps Research Institute La Jolla, CA, USA

Human Immunology Laboratory at Imperial College, London

Europe Regional Office, Amsterdam

Eastern Africa Regional Nairobi, Kenya

Southern Africa Regional Office Parktown, South Africa

India Regional Office and HIV Vaccine Translational Research Laboratory (joint venture with the Government of India), New Delhi

Click here to contact an IAVI office or lab
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SETH BERKLEY

CEO, Gavi, the Vaccine Alliance, and IAVI founder

"The spread of HIV cannot be fully controlled without a vaccine. I commend IAVI for their continued focus on this difficult goal, which I have no doubt science will ultimately solve. We look forward to the day when we work with countries to roll out the vaccine."

Board of Directors

Alex Godwin Coutinho, MD, MSc, MPH (Chair)

Executive Director, Infectious Diseases Institute

The Rt. Hon. the Lord Fowler

Former U.K. Secretary of State for Health and Social Security; Vice-Chair of All-Party Parliamentary Group on HIV and AIDS

Eric Paul Goosby, MD

Professor of Medicine, Global Health Sciences, University of California, San Francisco; U.S. Ambassador, former U.S. Global AIDS Coordinator and head of U.S. President's Emergency Plan on AIDS Relief (PEPFAR)

Paul H. Klingenstein

Managing Partner, Aberdare Ventures

Geoffrey Lamb, DPhil

Chief Economic and Policy Advisor, Executive Office, Bill & Melinda Gates Foundation

Adel A.F. Mahmoud, MD, PhD

Professor, Department of Molecular Biology and the Woodrow Wilson School of Public and International Affairs, Princeton University

Purnima Mane, PhD

President and Chief Executive Officer, Pathfinder International

Helen Rees, MD

Executive Director, Wits Institute of Reproductive Health and HIV, School of Clinical Medicine, University of Witwatersrand

Mary C. Tydings (Chair, Nominating Committee)

Managing Director, Russell Reynolds Associates, Inc.

Anne M. VanLent (Treasurer, Chair of Audit and Finance Committee)

President, AMV Advisors

Robin Weiss, PhD (Ex-Officio, Chair of the Scientific Advisory Committee)

Emeritus Professor of Viral Oncology, University College London

Marijke Wijnroks

Chief of Staff, The Global Fund to Fight AIDS, Tuberculosis and Malaria


Margaret G. McGlynn (Ex-Officio)

President and CEO, IAVI

Labeeb Abboud, JD (Secretary)

Senior Vice President & General Counsel, IAVI

IAVI Scientific Advisory Committee IAVI Senior Management Team
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MARK DYBUL

Executive Director, The Global Fund to Fight AIDS, Tuberculosis and Malaria

"It will take many organizations working together with sustained funding to develop an AIDS vaccine, which will be needed to defeat this global killer once and for all. IAVI's combination of innovative vaccine research and a broad range of partnerships is a promising model to get there."