Rockwood Clinic is participating in an international study to determine the effectiveness of an experimental preventative vaccine that in the words of JoAnn Vathis, a Rockwood research coordinator, could change womens lives by deterring cervical cancer.


Cervical cancer is the second most common cause of death from cancer in women worldwide, after lung cancer, and the No. 1 cause of death from cancer in the developing world, reports Rockwood in its quarterly newsletter.


Ninety percent of all cervical cancer is caused by a sexually transmitted virus called human papillomavirus, or HPV, says Dr. Sarah dHulst, who is one of Rockwood Clinics principal investigators in the study, which will involve 18,000 woman in 15 countries over four years. Rockwood is among 90 health-care providers participating in the study, which began recently.


Although there are more than 200 different strains of the HPV virus, the vaccine being studied is targeted at preventing the worst two, HPV-16 and HPV-18, which cause about 70 percent of all cervical cancers, says dHulst. The vaccine, its proposed, would keep women from contracting those two strains, but have no impact on those already having the virus.


Male carriers of the virus sometimes develop genital warts that might indicate the presence of HPV, and the only definitive way to know if a male has the virus is for him to undergo a specialized blood test that can cost thousands of dollars, she says.


If the vaccine is approved, it would be given primarily to young girls ages 10 to 13 before they become sexually active, says Vathis.


Seventy-five percent of all sexually active women get an HPV infection at some point in their lives, says GlaxoSmithKline Biologicals, of Belgium, that makes the vaccine and is paying for the study.


Cervical cancer often is detected early in women in developed countries, where women, often at six-month or one-year intervals, undergo five-minute, pain-free Pap smear evaluations to determine if cancer cells have developed in the lining of the cervix. With early detection, doctors can eliminate the cancer by a process of freezing cancerous portions of the cervix or by cutting away the outer layer of the cervix in a loop electrosurgical excision procedure, or LEEP. The latter procedure, however, can result in an added risk in future pregnancies, often by triggering premature births, dHulst says.


In extreme cases of cervical cancer, hysterectomies are performed to remove the entire uterus, but in some rare instances the cancer might already have spread beyond that point.


An estimated 500,000 cases of cervical cancer were reported worldwide last year, with about 60 percent of those incidences resulting in death, says Vathis. About 5,000 of the fatalities were in the U.S., she says.


Women should not be dying of cervical cancer, says Vathis.


Vathis, a licensed practical nurse who is also a clinical research coordinator at Rockwood Clinic, thinks the biggest beneficiary of the vaccine, which hasnt been named yet, would be women in underdeveloped countries, such as South Africa, where preventive health care isnt advanced and the rate of cervical cancer is the highest in the world. Its easier to prevent a disease than to treat it.


Rockwood Clinic has signed up 27 women to participate in the four-year study, and dHulst and Vathis are placing no limit on the number of women who can join the study by the May 31 enrollment deadline. Participants will receive free medical examinations for the next four years, free vaccine, and a stipend of $500 for their participation.


GlaxoSmithKline hopes to market the vaccine if it receives regulatory approval. Published reports have projected that approval could come next year, although its given country by country.


To participate in the study, women must be between 15 and 25 years of age, in good health, and neither pregnant nor planning to become pregnant in the first seven months after enrolling. Women who are or arent sexually active can enroll in the program, but those who are sexually active are more at risk for HPV, says Vathis.


Like other sexually transmitted diseases, the more partners you have, the more at-risk you are, she says.


dHulst expresses great interest in the vaccine study, but says, I am more excited about the participation of girls who have never had a Pap smear. Laboratory results from the smears will provide information about other STDs, such as gonorrhea and chlamydia. She says three participants in the young study already have been diagnosed and treated for chlamydia, a disease that can cause infertility.


Participants will be given three injections during the first six months of the study. Half of the women will receive the experimental vaccine, and the other half will receive a test control hepatitis A vaccine that helps prevent liver disease. Participants then must come into Rockwood Clinic every six months for a Pap smear.


Earlier studies of the vaccine achieved positive results. This phase 3 study is aimed specifically at evaluating the vaccines safety and efficacy. Vathis says its still unknown how long the vaccine remains effective in the body and combats the two targeted HPV strains. She suggests that a booster shot eventually could be recommended to extend the effective life of the vaccine.


Rockwood Clinics main office is at 400 E. Fifth, and it also operates 19 branch offices in Spokane County and one in Coeur dAlene. It employs a total of about 650 people and is currently participating in about 80 health-related studies, spokeswoman Chris Eriksen says.


Rockwood is the only cervical cancer vaccine study site in a multi-state area, and dHulst says its participation was due largely to the research efforts of pediatricianDr. Stephen R. Luber.