|Statement of Anthony S. Fauci, M.D.,
Director National Institute of Allergy and Infectious Diseases
On the Release of New Data from the HVTN 502 (STEP) HIV Vaccine Study
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
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
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.
Dr. Fauci is director of the National Institute of Allergy and
Infectious Diseases at the National Institutes of Health in Bethesda,
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