Promising cervical cancer vaccine to be studied at URI
100 women ages 16 to 23 sought for clinical study
KINGSTON, R.I. -- June 7, 2002 -- The Clinical Trials section of the University of Rhode Island Health Services has been selected as one of 13 sites in the country to conduct clinical trials of a promising vaccine for cervical cancer, the second most common cause of cancer-related death among women in the United States.
URI is now recruiting 100 women between the ages of 16 and 23 to participate in the study, which is sponsored by a major pharmaceutical company. A total of 4,000 women nationwide are being sought. Following screening, volunteers will be administered the vaccine three times over the course of six months and then monitored a physical exam and Pap test -- twice a year for several years thereafter. All other regular gynecological care will be provided free to participants for the duration of the study, such as birth control, and financial compensation will be provided for time and travel.
"Were recruiting students, community members, and any other women interested in participating. We also want to raise awareness about cervical cancer and the virus that causes it because its a new subject that hasnt been addressed in schools," said Dr. David Whitaker, medical director of clinical trials at URI. (Shown above with Clinical Trials nurse practitioner June Newman.)
The Federal Drug Administration and the pharmaceutical companies provide oversight of all clinical trials in the U.S to ensure that the trials are conducted safely. "This clinical trials process is the way all new medicines and vaccines are developed," Whitaker said. "Any medicine youve ever taken has come through this process."
According to Whitaker, it has been irrefutably established that the human papillomavirus (HPV), the most common sexually transmitted disease, is the cause of every abnormal Pap smear and 99 percent of cervical cancer cases. It affects 60 percent of all young women, though most are not aware of it because in most cases there are no visible signs of infection.
"There are about 80 different strains of HPV, and several of them are known to cause cancer," explained Whitaker. "But there is currently no way to prevent the virus other than abstinence and there is no treatment or cure for it. What is known, though, is that the risk of contracting HPV is a staggering 15 percent per partner, so multiple sex partners increases the risk." Condom use does not necessarily prevent infection.
Approximately 45,000 women in the U.S. are diagnosed with cervical cancer every year, and 5,000 per year die from the disease. In developing countries, where women have little access to gynecological care, the death rate is significantly higher. About 10 million American women most in their late teens and twenties have active HPV infections.
Whitaker said that some women infected with the cancer-causing strains of the virus dont develop cancer because their immune system successfully fights it. "Some women can carry the virus and transmit it to others but never get cancer. Or it can be dormant in their system for decades."
The vaccine being studied is a yeast-based vaccine made in a similar way to the Hepatitis B vaccine that has been proven safe and effective, even for use on infants. The yeast-based technology was pioneered by Merck Pharmaceuticals and GlaxoSmithKline more than 15 years ago. Its just the second vaccine developed to fight cancer, and after five years of study it has been found to be well tolerated.
The clinical study being launched this spring is the third and final phase of a lengthy testing process for the vaccine. Following animal testing, the first phase of human trials was a short-term study to determine the proper dosage levels and potential side effects. URI participated in phase two, which involved longer-term trials to test the effectiveness of the vaccine. Phase two began in 1998 and will conclude this fall. The third phase is similar to phase two but with a larger number of participants.
Whitaker and the majority of the medical community are optimistic that this vaccine will substantially reduce cervical cancer within a generation. "Im having trouble containing my exuberance about this vaccine," he said. "Theres a lot of excitement about it. There is no question in my mind that this is the most important project that Ill be involved with in my entire career."
URI was selected as a study site because of its long-standing relationship with many of the major pharmaceutical companies. "Clinical trials have been conducted here for more than 20 years, so when the pharmaceutical companies were looking for a site in New England to evaluate this vaccine, they chose us," said Whitaker.
For more information or to volunteer to participate in the trials, contact URI Clinical Trials nurse practitioner June Newman at 401-782-2570 or firstname.lastname@example.org.
For Information: Dr. David Whitaker 782-2570, Todd McLeish 874-7892