At the AIDS Vaccine 2001 meeting in Philadelphia Sept. 5-8, Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), will review recent research progress as well as key challenges in the search for a vaccine against the human immunodeficiency virus (HIV). He also will detail the robust commitment of NIH and its domestic and international research partners to HIV vaccine development.
Dr. Fauci's keynote lecture, entitled NIAID and Vaccine Research: Science and Policy, is scheduled for Wednesday, Sept. 5 at 5:00 p.m. at the Philadelphia Marriott Hotel. The slides from Dr. Fauci's lecture will be available simultaneously at http://www.niaid.nih.gov/director/director.htm. In addition, the Web site for the meeting, http://www.AIDSvaccine2001.org, will feature videocasts of his and other major lectures. Dr. Fauci also will participate in a press conference that same day at 3:30 p.m. in Room 310 of the hotel.
Despite recent progress in treatment and prevention, HIV disease and AIDS continue to exact an enormous toll throughout the world. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), more than 58 million people worldwide have been infected with HIV since the beginning of the pandemic; 22 million of these individuals have died. An estimated 5.3 million people, most of whom live in developing countries, were infected with HIV in the year 2000 alone.
"Historically, vaccines have provided safe, cost-effective and efficient means of preventing illness, disability and death from infectious diseases," says Dr. Fauci. "The development of a safe and effective vaccine for HIV infection is a central goal of AIDS research and a necessary tool to bring the HIV epidemic under control."
Dr. Fauci adds: "NIAID has played a major role in the development of vaccines for many other important diseases, such as hepatitis B, Haemophilus influenzae type B, pertussis and pneumococcal infections. We fully expect that the experience, expertise and commitment of NIAID-funded investigators and our partners in the United States and abroad will lead to the development of a useful HIV vaccine as well."
Ramping Up Research Resources
To speed the pace of HIV vaccine discovery, NIH has increased HIV vaccine research funding more than six-fold since 1990, to an estimated $356.6 million for fiscal year (FY) 2002. NIAID is the lead NIH institute for HIV vaccine research, and accounts for more than 75 percent of NIH vaccine spending. At NIAID, an estimated $450.7 million will be devoted to all vaccine research in FY 2002, with 61 percent of that total ($276.5 million) dedicated to HIV vaccine development.
"The field of vaccine research owes great thanks to the largesse of the American people, the Administration and Congress for making these resources available," Dr. Fauci notes.
In addition to an extensive portfolio of basic research, NIAID-supported investigators are testing diverse HIV vaccine strategies in animal models and human volunteers. NIAID recently launched the HIV Vaccine Trials Network (HVTN, http://www.hvtn.org), a global research network that will conduct all phases of clinical HIV vaccine research. FY 2002 funding for the HVTN is an estimated $35.6 million. The HVTN, formerly known as the AIDS Vaccine Evaluation Group, has already provided a wealth of data that contribute to many researchers' optimism that a safe and effective HIV vaccine can be developed. This network will be central to the NIAID's capabilities to perform clinical testing on a variety of candidates in the HIV vaccine "pipeline."
Another important NIAID initiative is the Comprehensive International Program of Clinical Research on AIDS (CIPRA, http://www.niaid.nih.gov/daids/cipra/). CIPRA, with estimated FY 2002 funding of $15.0 million, will provide long-term support for development of research infrastructure and fundamental laboratory and clinical studies of practical and affordable methods for prevention and treatment of HIV/AIDS in international settings, especially in developing regions. These efforts will enhance the ability of host countries to conduct relevant research, to prepare for and participate in large-scale HIV therapeutic, vaccine and prevention clinical trials, and to study diagnostic and treatment interventions in local populations.
On the NIH campus, NIAID's Dale and Betty Bumpers Vaccine Research Center (VRC, http://www.niaid.nih.gov/vrc) conducts all stages of HIV vaccine research, from basic investigations to clinical trials. FY 2002 funding for the VRC is an estimated $40.0 million. The VRC recently began its first clinical trial of a candidate HIV vaccine: a Phase I study of a product made from the DNA of two HIV proteins called "gag" and "pol." When injected into a person, the viral DNA induces the production of small amounts of the HIV proteins but not the intact virus. This study will see if the body mounts an immune response to these proteins. This candidate HIV vaccine, like all other NIAID-sponsored candidates, cannot lead to HIV infection in people.
NIAID also supports numerous other programs in HIV vaccine development, such as a network of Simian Vaccine Evaluation Units; and HIV Vaccine and Design Development Teams, public-private partnerships of scientists from industry and/or academia, which have identified specific vaccine concepts amenable to accelerated development.
The Research Pipeline
In preclinical and clinical studies, NIAID-supported investigators are testing a wide range of vaccine strategies such as recombinant HIV proteins, synthetic peptides, recombinant viral vectors, recombinant bacterial vectors, DNA vaccines and synthetic HIV-like particles. Currently, NIAID has a diverse research "pipeline" of approximately two dozen vaccine candidates. Approximately 16 of these candidates are directed against the subtypes ("clades") of HIV found in the developing world, such as clade A (common in Africa) and clade C (common in Africa and Asia).
Among many promising studies, several groups working with vaccines against an HIV-like virus known as simian immunodeficiency virus (SIV) or a combination virus called SHIV (made of components of both HIV and SIV) have shown that vaccinated monkeys challenged with lethal doses of virus do not become sick, and maintain very low levels of virus in their bloodstream.
"A number of studies suggest that a vaccine that does not prevent HIV infection, but slows the course of disease may not only benefit vaccinated individuals, but could slow the dynamics of the HIV epidemic by lowering viral load in infected individuals and thereby reduce transmissibility of the virus," says Dr. Fauci.
Despite many exciting advances, a number of obstacles remain in the search for a safe and effective HIV vaccine.
"Perhaps the greatest obstacle to HIV vaccine development is an insufficient understanding of the correlates of immune protection, which are better understood for other viral diseases," says Dr. Fauci. "Among many challenges, it is essential to further illuminate the roles of cytotoxic T lymphocytes and antibodies in HIV disease. Other important challenges to HIV vaccine development include the high rate of HIV mutation within populations and individuals, the limitations of all current animal models of HIV disease, and the fact that HIV integrates itself into the DNA of host cells, where it can escape immune surveillance."
AIDS Vaccine 2001 is sponsored by the Foundation for AIDS Vaccine Research and Development in Alexandria, Virginia. Co-sponsors include agencies of the NIH (NIAID, Office of AIDS Research, and the National Cancer Institute), the Centers for Disease Control and Prevention, UNAIDS, the World Health Organization, and the Agence Nationale Recherches sur le SIDA (France).
NIAID is a component of the National Institutes of Health (NIH). NIAID conducts and supports research to prevent, diagnose and treat illnesses such as HIV disease and other sexually transmitted diseases, tuberculosis, malaria, asthma and allergies. NIH is an agency of the U.S. Department of Health and Human Services.
Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.