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Topic Name: The release of new data from the HVTN and NIAID HIV vaccine study

Category: Biomedical

Research persons: NIAID and its study partners

Location: National Institute of Allergy and Infectious Diseases, United States

Details

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.

The above discussion was the statement of Anthony S. Fauci, M.D., director, National Institute of Allergy and Infectious Diseases.

About National Institute of Allergy and Infectious Diseases

National Institute of Allergy and Infectious Diseases (NIAID) is a component of the National Institutes of Health (NIH), which is an agency of the United States Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

The NIAID-funded Influenza Genome Sequencing Project is a collaborative effort designed to increase the genome knowledge base of influenza and help researchers understand how flu viruses evolve, spread and cause disease.

About HIV Vaccine Trials Network

The HIV Vaccine Trials Network is a collaboration between physicians, scientists and activists that conducts clinical trials seeking a safe and effective HIV vaccine. They review potential vaccines for safety, immune response and efficacy. The HVTN is currently involved in seventeen vaccine trials. They are supported by the National Institute of Allergy and Infectious Diseases of the U.S. National Institutes of Health. They are headquartered at the Fred Hutchinson Cancer Research Center in Seattle. The HVTN has started the first large scale HIV vaccine trials in Africa, with financial assistance from SA Aids Vaccine Initiative. This study will last four years and include up to 3000 participants.

About Merck & Co., Inc.

Merck & Co., Inc. also known as Merck Sharp & Dohme or MSD outside the USA and Canada, is one of the largest pharmaceutical companies in the world. The headquarters of the company is located in Whitehouse Station, NJ. It was established in 1891 as the United States subsidiary of the German company now known as Merck KGaA. In common with many other German assets in the United States, Merck & Co. was confiscated in 1917 during World War I and set up as an independent company. It is currently one of the top 7 largest pharmaceutical companies in the world both by capital and revenue.

About Dr. Anthony S. Fauci

Dr. Anthony S. Fauci, a native of Brooklyn, New York, received his M.D. degree from Cornell University Medical College in 1966. He then completed an internship and residency at The New York Hospital-Cornell Medical Center. In 1968, Dr. Fauci came to the National Institutes of Health (NIH) as a clinical associate in the Laboratory of Clinical Investigation (LCI) at the National Institute of Allergy and Infectious Diseases (NIAID). In 1980, he was appointed Chief of the NIAID Laboratory of Immunoregulation, a position he still holds. In 1984, Dr. Fauci became Director of NIAID, where he oversees an extensive research portfolio of basic and applied research to prevent, diagnose, and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies. The NIAID budget for fiscal year 2007 is approximately $4.4 billion. Dr. Fauci serves as one of the key advisors to the White House and Department of Health and Human Services on global AIDS issues, and on initiatives to bolster medical and public health preparedness against emerging infectious disease threats such as pandemic influenza.