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.
UCLA 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 a amazing
triumph.”
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