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CONTACT: BECKY SOGLIN
2130 Medical Laboratories
Iowa City IA 52242
(319) 335-6660; fax (319) 335-9917
e-mail:becky-soglin@uiowa.edu

Release: Immediate

UI testing vaccine for cervical cancer

IOWA CITY, Iowa -- Clinical trials in the department of obstetrics and gynecology at the University of Iowa College of Medicine will help determine whether a recently developed vaccine prevents cervical cancer.

The department received a $529,000 grant from Merck and Co., Inc. in West Point, Pa., to conduct phase II testing of a vaccine for human papillomavirus 16 (HPV-16). The testing will reveal whether the vaccine, developed by Merck, is safe, well tolerated and effective.

HPV-16 has been identified as one of two strains of HPV believed to cause 90 percent of all cervical cancer cases in women, leading to nearly 5,000 deaths per year in the United States and 500,000 worldwide. It is estimated that 20 million Americans are infected with HPV, many of them women in their late teens or early 20s. HPV-16 infection occurs through sexual activity and can lead to cancer by causing changes in the cells of a woman's cervix.

The three-year study will be conducted at the Iowa City Family Planning Clinic at the UI Hospitals and Clinics. The investigators will recruit a total of 120 women ages 16 to 23 to take part in the clinical trials. Screening of participants began in October, and testing has already begun.

The principal investigator is Dr. Kevin Ault, UI assistant professor of obstetrics and gynecology. Other Iowa investigators in the department are Jan Bergman, advanced registered nurse practitioner and coordinator of the study, and Paula Laube, physician assistant and director of the Iowa City Family Planning Clinic. The UI is one of 15 institutions nationwide selected to conduct the HPV-16 vaccine study, which will involve a total of 2,000 women.

"A successful vaccine will save thousands of lives and billions of dollars in health care costs," said Ault, who estimated that a vaccine would be available within the decade. In Iowa nearly 150 women are diagnosed with cervical cancer each year.

The symptoms of HPV-16 infection are largely asymptomatic or "silent." An untreated individual can remain infected for years, even decades, and easily spread the infection to other sexual partners, Ault said.

According to a study recently released by the American Social Health Association for the Henry J. Kaiser Foundation, HPV incurs the highest direct medical costs, $1.6 billion annually, of all sexually transmitted diseases other than HIV, the virus that causes AIDS.

In the HPV-16 study, participants will receive either three injections of the vaccine or a placebo injection. Follow-up includes three years of annual gynecological exams to test participants for the presence of HPV infection or precancerous cells.

Ault said the vaccine uses a laboratory-engineered protein particle that resembles HPV-16, but is not the actual virus. "When the vaccine is administered, the body should believe it's infected and start producing antibodies that protect the cells lining the cervix and vagina," Ault said. "The results of the study should reveal whether the vaccine protects women from HPV infection."

The Merck grant supports the recruitment of participants, research costs, exams and laboratory work and compensation of participants' time. "The study is a good industry-academia joint effort," Ault said.

If the phase II trials show that the vaccine works, a phase III trial will further test the vaccine and include testing of other strains of human papillomavirus that cause genital warts.

Healthy, non-pregnant, unmarried females ages 16 to 23 years who are interested in participating in the current study are encouraged to call Jan Bergman at (319) 353-6707, (319) 356-2539 or (888) 884-8946. Information is also available online at http://obgyn.uihc.uiowa.edu/hpvstudy.htm

12/21/98