CONTACT: BECKY SOGLIN
2130 Medical Laboratories
Iowa City IA 52242
(319) 335-6660; fax (319) 335-9917
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