CONTACT: BECKY SOGLIN
Iowa City IA 52242
(319) 335-6660; fax (319) 384-4638
Release: Nov. 21, 2002
Note to Editors: This release includes information from the University of
Washington Office of Health Sciences and Medical Affairs, http://depts.washington.edu/hsnews/directory.html.
Photo: Kevin A. Ault, M.D., UI assistant professor of obstetrics and
UI Health Care physician contributes to finding of effective HPV-16 vaccine
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
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
"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.
University of Iowa Health Care describes the partnership between
the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and
Clinics and the patient care, medical education and research programs and
services they provide. Visit UI Health Care online at www.uihealthcare.com.