Earlier this week, the Centers for Disease Control and Prevention announced that it had selected UR as one of four national sites charged with assessing the effectiveness and impact of the new Human Papilloma Virus (HPV) vaccine. The study is sponsored by the CDC and collaborates with the Emerging Infections Program – a nationwide network of state health departments and CDC officials collaborating with local healthcare providers to assess the demographic impact of emerging infections and those measures instituted to combat them.

“Specifically, the study is an attempt to determine how many people are receiving the vaccine and whether or not it is having a measurable impact on rates of cervical cancer and its precursor lesions,” Director of the Office of Science and Public Health, New York State Department of Health and director of the New York State EIP Dale L. Morse, M.D., M.S. said.

Director of the URMC Center for Community Health Nancy Bennet, M.D., M.S. stressed the importance of the study.

“This study is critical because many of the fundamental questions about a new vaccine cannot really be answered until we have been able to look at its impact on a broad population over a long period of time,” she said.

Obstetrics and gynecology physicians from all three of the Monroe County region’s healthcare systems and pathologists from its three major laboratories will work together to determine how quickly the new vaccine is pervading through the Rochester-area community. They will accomplish this by comparing those test results indicating an acute and invasive form of dysplasia – a definite precursor of cervical cancer – with vaccination rates. The investigators will pay special attention to determining whether or not those individuals testing positive for cervical cancer, or its precursor dysplasia had been vaccinated for HPV – which usually leads to dysplasia and sometimes cervical cancer. Dysplasia can take many years to become cervical cancer, so attempting to track it instead of full-blown

cases of cervical cancer allows for a much more rapid analysis of the HPV vaccine’s impact and efficacy. Nevertheless, because the CDC’s primary recommendation is for routine vaccination of girls 11-12 years of age, it will be several years before the study can come to any well-founded conclusions.

News of UR’s selection for inclusion in the study comes at the heels of the FDA’s approval of Gardasil – manufactured by Merck – earlier this year. Cervarix, a competing HPV vaccine manufactured by GlaxoSmithKline, is currently undergoing FDA trials and is expected to gain the agency’s endorsement later on this year.

Both Gardasil and Cervarix use technologies primarily developed over the last 20 years at the UR. Some sources have indicated that Cervarix might outperform Gardasil in effectiveness, but the latter vaccine has already established a significant foothold in the United States which will aid in its sales.

HPV is the most common sexually transmitted infection in the United States of America. Over 6.2 million Americans are infected annually. Three quarters of the sexually-active population will contract some form of HPV in their lifetimes. The immune system generally defeats most HPV strains to the extent that the vast majority of infected individuals never even realize they have the infections. However, persistent infection with a so-called high-risk HPV strain like type 16 or 18 can lead to precancerous lesions, dysplasia and eventually cervical cancer.

Sexually active women who do not submit to regular diagnostic screenings significantly increase their chances of developing cervical cancer. The disease is diagnosed in about 14,000 women a year and annually ends up killing around 3,900 nationwide. HPV types 16 and 18 are responsible for 70 percent of all cervical cancer diagnoses. Accordingly, the new vaccines were developed to ferment immunity primarily against these two types.

Singh is a member of the class of 2008.



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