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(U-WIRE) LOS ANGELES -- In two weeks, a vaccine clinically proven to prevent four volatile subtypes of the human papilloma virus will be available to the public, a landmark in the health sciences as this vaccine could help prevent future cases of genital warts and cervical cancers caused by HPV.
The University of California-Los Angeles has played a vital role in validating the vaccine, which scientists hope can prevent almost 1 million new STD cases each year in the United States alone.
Merck, the pharmaceutical company lauded for producing a new STD vaccine that prevents four strains of HPV, recently announced its plans to distribute the vaccine by the end of July, thanks in part to clinical studies done at UCLA and 15 other research sites.
The vaccine was recently approved by the Food and Drug Administration and has been shown to prevent nearly all new HPV 6, 11, 16 and 18 infections, the four most harmful subtypes of HPV.
Gardasil, the HPV vaccine, is approved for females ages 9 to 26, a range into which most UCLA students fall. It will be effective for those who have not contracted any of the four HPV subtypes, and most effective for those who are not yet sexually active.
The vaccine is administered three times over a six-month period to prevent two strains of the virus known to cause protruding lesions in the genital area, more commonly termed "genital warts," and another two strains that lead to cervical cancer in women.
Evi Desser, nurse practitioner supervisor at the Arthur Ashe Student Health and Wellness Center, said the vaccine costs $406, but those with the Student Health Insurance Plan will get the usual immunization benefit of 90 percent coverage once their $250 deductible is met.
Desser, whose secondary job is to oversee the Ashe immunization clinic and determine the suitability of a vaccine for UCLA's college population, said the center will likely start with a moderate order of vaccines and monitor the demand thereafter. She said she expects demand to increase in the fall because more students will be on campus.
"The incidence of cervical cancer in those vaccinated should decrease dramatically, which will be a boon for future generations in terms of reduced disease burden and health care costs," Desser said.
After Merck's preliminary trials were 100 percent effective against the one type of HPV it tested, it approached UCLA for a second set of trials.
To develop the product, Merck consulted Edward Wiesmeier, then the medical director of the ASHE Center, and Dorothy Wiley, an epidemiologist and faculty member at the UCLA School of Nursing, with their proposal to continue clinical trials. Wiley and Wiesmeier became the principal investigators and began the eight-year HPV vaccine study.
"One-hundred UCLA women were followed up to four years after their first study visit. About half of the women received three doses of study vaccine and one-half received placebo," said Emmanuel Masongsong, a research associate and study coordinator, of the study process.
The first wave of promising results came to shore in November 2002 when Dr. Laura Koutsky of the study site at the University of Washington published the first results in the New England Journal of Medicine on behalf of the investigator team.
The study's results showed that the vaccine prevented all infections in women who completed all vaccines as prescribed and that those women also showed negative results for the one type of HPV being tested -- HPV 16, which is known to cause cervical cancer.
Though the initial studies done at UCLA used a vaccine for HPV 16 alone, the follow-up studies focused on developing a vaccine that would also prevent other infections, Masongsong said.
This achievement in the health sciences has drawn international attention because up until now, most women who showed Pap smear test abnormalities were tested repeatedly over the course of one to two years and most had to "wait and see," Masongsong said. Thus, "vaccine strategies to prevent HPV infections related to cervical and other anogenital cancers is revolutionary."
Desser hopes the vaccine will prevent the "anxiety and inconvenience for those college students affected" by genital warts and Pap smear abnormalities.
But aside from the accolade voiced by the science community, the vaccine's introduction also drew criticism when the notion of mandatory HPV vaccination was considered.
In a story reported by USA Today, the Family Research Council, a conservative group, did not speak out against giving the shot to young girls, but did oppose making it one of the vaccines required before children can enroll in school.
The council and other similar groups say giving the vaccination to children would be like making it acceptable for adolescents to become sexually active.
The Advisory Committee on Immunization Practices recommended that routine Gardasil vaccines be issued to 11- and 12-year-old girls, but that such vaccinations should not be mandatory.
Wiesmeier also shared his excitement about the results of the study.
"Though we won't be eliminating cervical cancer totally in the next 10 years," there will be a much better grasp of preventing women and men from being exposed to these types of diseases with repeated research and studies, Wiesmeier said.
"It has been a long process and obviously a lot of hard work so we're glad to have encouraging results and a positive buzz in the media, and it is gratifying to see the renewed hope people now have with regard to cervical cancer," Masongsong said.
"Having known the cause of this disease for as long as we have, and finally discovering a way to subvert it, is an amazing triumph."
(C) 2006 Daily Bruin via U-WIRE
