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The release of new data from the HVTN 502 HIV vaccine study
November 08, 2007Statement of Anthony S. Fauci, M.D., director, National Institute of Allergy and Infectious Diseases
The new analyses revealed today from the STEP HIV vaccine clinical trial are both disappointing and puzzling. At this time, the data offer no clear explanations as to why the vaccine showed no measurable efficacy or why among individuals with background immunity to the adenovirus vector, there were more HIV infections in the vaccinees as compared to those in the placebo group. Analyses of the STEP data are continuing, and it will take some time before we fully understand these results.
NIAID and its study partners, Merck & Co., Inc., and the HIV Vaccine Trials Network (HVTN), fully recognize the importance of these results to the volunteers who participated in the study and the larger scientific community. We are committed to working together to better understand the data from this study, and disclosing new findings as they become available.
Certainly, the failure of this HIV vaccine product was unexpected. But this setback should not and can not diminish our commitment to developing an effective HIV vaccine. Every day, another 12,000 people become infected with HIV, most of whom live in resource-poor countries. Approximately, 40 million people are currently living with HIV infection, and more than 25 million people with AIDS have died. Last year alone, an estimated 4.3 million new HIV infections occurred worldwide.
Historically, vaccines have been the most effective weapon against infectious diseases, such as polio, measles, mumps and smallpox. The goal of developing a safe and effective HIV vaccine is a key goal of HIV research today. However, the complex and unique nature of HIV has presented a formidable challenge to developing an effective vaccine.
In the absence of an HIV vaccine, there are proven methods for preventing HIV transmission that we, as a global community, must implement on a wider scale. These methods include HIV/AIDS education and behavior modification; condom usage to prevent sexual HIV transmission; medically supervised adult male circumcision in appropriate settings; needle exchange programs to curb bloodborne HIV transmission among injection drug users; and the use of antiretroviral drugs in HIV-infected pregnant women to prevent mother-to-child HIV transmission. Although none of these interventions is completely effective on its own, when used in combination they can have a significant impact on HIV prevention. Less than 20 percent of the world's population currently has access to proven HIV prevention services, but this figure is growing with the efforts of programs such as the President's Emergency Plan for AIDS Relief, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and many others.
In addition to existing HIV prevention tools, we must create new, evidence-based approaches to HIV prevention, such as topical anti-HIV gels or creams that could be applied prior to sexual intercourse; preventive regimens of antiretroviral medications; and, especially, a vaccine. A setback in a given clinical trial is no reason to lessen our commitment to tackling the scientific challenges inherent in this field of research. What we learn from the STEP study will inform ongoing and future HIV vaccine research.
We must regroup and recommit ourselves to developing an HIV vaccine and other new prevention weapons while providing proven HIV prevention tools to those who need them. In the global fight against the HIV/AIDS pandemic, every prevention tool is of paramount importance.
NIH/National Institute of Allergy and Infectious Diseases
Certainly, the failure of this HIV vaccine product was unexpected. But this setback should not and can not diminish our commitment to developing an effective HIV vaccine. Every day, another 12,000 people become infected with HIV, most of whom live in resource-poor countries. Approximately, 40 million people are currently living with HIV infection, and more than 25 million people with AIDS have died. Last year alone, an estimated 4.3 million new HIV infections occurred worldwide.
Historically, vaccines have been the most effective weapon against infectious diseases, such as polio, measles, mumps and smallpox. The goal of developing a safe and effective HIV vaccine is a key goal of HIV research today. However, the complex and unique nature of HIV has presented a formidable challenge to developing an effective vaccine.
In the absence of an HIV vaccine, there are proven methods for preventing HIV transmission that we, as a global community, must implement on a wider scale. These methods include HIV/AIDS education and behavior modification; condom usage to prevent sexual HIV transmission; medically supervised adult male circumcision in appropriate settings; needle exchange programs to curb bloodborne HIV transmission among injection drug users; and the use of antiretroviral drugs in HIV-infected pregnant women to prevent mother-to-child HIV transmission. Although none of these interventions is completely effective on its own, when used in combination they can have a significant impact on HIV prevention. Less than 20 percent of the world's population currently has access to proven HIV prevention services, but this figure is growing with the efforts of programs such as the President's Emergency Plan for AIDS Relief, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and many others.
In addition to existing HIV prevention tools, we must create new, evidence-based approaches to HIV prevention, such as topical anti-HIV gels or creams that could be applied prior to sexual intercourse; preventive regimens of antiretroviral medications; and, especially, a vaccine. A setback in a given clinical trial is no reason to lessen our commitment to tackling the scientific challenges inherent in this field of research. What we learn from the STEP study will inform ongoing and future HIV vaccine research.
We must regroup and recommit ourselves to developing an HIV vaccine and other new prevention weapons while providing proven HIV prevention tools to those who need them. In the global fight against the HIV/AIDS pandemic, every prevention tool is of paramount importance.
NIH/National Institute of Allergy and Infectious Diseases
HIV Vaccine News and Current HIV Vaccine Events RSSNIAID describes challenges, prospects for an HIV vaccine
Events of the past year in HIV vaccine research have led some to question whether an effective HIV vaccine will ever be developed. In the August 28 edition of the New England Journal of Medicine, officials from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, examine the extraordinarily challenging properties of the virus that have made a vaccine elusive and outline the scientific questions that, if answered, could lead to an effective HIV vaccine.
UT Pathologists Believe They Have Pinpointed Achilles Heel of HIV
Human Immunodeficiency Virus (HIV) researchers at The University of Texas Medical School at Houston believe they have uncovered the Achilles heel in the armor of the virus that continues to kill millions.
HIV Infection Stems From Few Viruses
A new study reveals the genetic identity of human immunodeficiency virus (HIV), the version responsible for sexual transmission, in unprecedented detail.
Exhaustion of HIV-specific T cells may be caused by chronic exposure to virus
The "exhaustion" of immune cells that target HIV appears to result from chronic exposure to the virus, specifically exposure to the particular protein segments targeted by the pathogen-killing HIV-specific CD8 T cells.
Scripps research scientists devise approach that stops HIV at earliest stage of infection
Researchers at The Scripps Research Institute have developed a new two-punch strategy against HIV and they have already successfully tested aspects of it in the laboratory.
Nanoemulsion vaccines show increasing promise
A novel technique for vaccinating against a variety of infectious diseases - using an oil-based emulsion placed in the nose, rather than needles - has proved able to produce a strong immune response against smallpox and HIV in two new studies.
New insights into vaccination for HIV
A group of Australian researchers at the Universities of Melbourne and New South Wales have developed new tools and paradigms to understand immune evasion from HIV.
Keeping young South Africans in school: A 'social vaccine' against AIDS
A study published today in the Journal of Epidemiology and Community Health suggests that secondary school attendance is linked to lower risk of HIV infection among young people in rural South Africa.
Uncovering the Achilles' heel of the HIV-1 envelope
New structural details illustrate how a promising class of antibodies may block human immunodeficiency virus (HIV)-1 infection and reveal valuable clues for design of an effective HIV-1 vaccine.
FDA petition would protect public from dangerous drugs
In a petition filed today with the U.S. Food and Drug Administration, an international coalition of scientists and doctors seeks to compel the agency to stem the flood of dangerous drugs reaching American consumers by mandating the use of scientifically superior non-animal testing methods when those alternatives exist.
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