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Release: Nov. 21, 2002

Note to Editors: This release includes information from the University of Washington Office of Health Sciences and Medical Affairs,

Photo: Kevin A. Ault, M.D., UI assistant professor of obstetrics and gynecology

UI Health Care physician contributes to finding of effective HPV-16 vaccine

An experimental vaccine appears to prevent a form of human papillomavirus (HPV) that is linked to nearly half of all cervical cancer cases, according to a University of Washington (UW) School of Public Health and Community Medicine study that involved a University of Iowa Health Care physician.

The finding, reported in today's New England Journal of Medicine, found that the vaccine appears to prevent infection with HPV-16, which annually is linked to more than half of the approximately 500,000 cases of cervical cancer worldwide. The investigation involved nearly 2,400 female participants ages 16 to 23 at 16 centers nationwide. The study was funded by Merck Research Laboratories, which produces the experimental vaccine.

The principal investigator was Laura Koutsky, Ph.D., professor of epidemiology at the UW School of Public Health and Community Medicine in Seattle. Kevin A. Ault, M.D., UI assistant professor of obstetrics and gynecology, was an author on the study and the principal investigator for the University of Iowa site, where 250 women participated through the UI Family Planning Clinic.

"An HPV-16 vaccine is so important to women's health because HPV-16 is closely associated with cervical cancer," Ault said. "A successful vaccine has the potential to save thousands of lives."

Participants in the study received either a placebo (inactive substance) or the vaccine. The study was random, meaning neither the volunteers nor the researchers initially knew who received the vaccine and who received the placebo.

The study found 41 cases of HPV-infection among the women receiving the placebo, whereas there were no HPV-16 infections for women receiving the vaccine. The paper included information from the first two follow-up years of the study; the researchers expect to follow the women for an additional two years.

"More studies involving a larger group of women need to be done, but we are very excited thus far about the lifesaving potential of vaccines to prevent cervical cancer-related death in large parts of the world," Koutsky said.

The HPV-16 virus affects approximately 20 percent of the adult population. Ault explained that condoms are only partially effective for HPV-16 because the virus can develop on areas not covered by condom.

In women, the vaccine appears to prevent HPV-16 from lingering in the genital tract where, in addition to causing a lesion, it can be transmitted to a sex partner.

"Fifty percent of cervical cancer cases are caused by HPV-16 but that means that 50 percent of the cases are not. There are other types of HPV that need to be studied," Ault said.

Because a vaccine that eliminates all HPV types linked with cervical cancer is years away from being widely available, the investigators strongly encouraged women to continue to undergo routine Pap smear screening.

"These are very promising results, but the bottom line is that until a vaccine is fully tested and available, the best way to prevent cervical cancer is to participate in routine Pap screening," Koutsky said.

The next step in the research to study a vaccine that targets four types of HPV, including HPV-16. The UI will participate in that investigation.

Ault added that he was impressed by how much study volunteers at the UI already knew about HPV when they enrolled in the investigation.

"Only about 10 percent of people usually understand that HPV causes cervical cancer, but most volunteers realized this and said it was their motivation for being in the study," he said.

As with all medical care, it is best to consult with your personal physician before making any changes to your health care routine.

Koutsky, Ault and one other investigator on the team have received consulting fees and research support from Merck during the past two years. In addition, Ault has received a consulting fee and research support from 3M and research support from GlaxoSmithKline within the past six years.

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