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In those women who completed the protocol the vaccine was 100 percent
effective against persistent HPV16/18 infections.
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LEBANON, NH ? An international clinical trial directed by Dr. Diane
Harper of Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical
Center (DHMC) and Dartmouth Medical School has shown extremely promising
results for a vaccine against the most common causes of cervical cancer.
Writing in the lead article of this week's issue of The Lancet,
Harper and her fellow authors said the vaccine has the potential to
greatly reduce deaths from cervical cancer, one of the leading causes of
cancer mortality among women worldwide. The vaccine is targeted to
immunize against two different types of high risk Human Papillomavirus
(HPV-16 and HPV-18) that cause an estimated 70 percent of cervical
cancer cases.
HPV is a commonly occurring infection, transmitted by skin to skin
contact, most commonly through normal sexual interactions. Although most
cases of HPV resolve themselves through natural immunity, a percentage
of cases will progress to cervical cancer. Currently, an estimated
280,000 women die from cervical cancer each year, most of them in the
developing world. Of the 500,000 cases of cervical cancer diagnosed
annually, 70 percent are attributed to infection from HPV-16 and18. The
five year prevalence of cervical cancer worldwide ? in other words, the
number of women in any five year period of time with cervical cancer ?
is 1.4 million.
Study details
In the blinded, randomized trial of 1,113 women from throughout the
U.S., Canada, and Brazil, participants received 3 doses of the
experimental vaccine or a placebo over 6 months. At 27 months of
follow-up, the vaccine showed an extremely high rate of efficacy, the
authors write. In those women who completed the protocol ? receiving all
three shots and participating in all scheduled testing and follow-up ?
the vaccine was 100 percent effective against persistent HPV16/18
infections.
Significantly, the efficacy was only slightly reduced for those women
who did not fully comply with the protocol ? receiving only one or two
of the 3 shots or not completing all scheduled follow-up appointments.
In that group, the vaccine proved 95 percent effective against
persistent HPV infection and 93 percent against cytologic abnormalities
associated with HPV 16/18, and complete protection from cervical tissue
changes due to HPV16/18.
Harper, a clinician who actively treats women in the Obstetrics and
Gynecology section at DHMC, as well as a researcher, is internationally
recognized for her pioneering work on HPV. She called the results of the
study "extremely exciting and encouraging. We believe this shows
enormous potential to eradicate the great majority of cervical cancers
worldwide."
Harper noted that while other vaccines against HPV are currently
being tested, this trial is notable because it is the first to target
two viruses with one vaccine. "Our trial results showed a high degree of
safety, with no adverse effects to the participants, and highly
significant and complete protection against persistent infection. This
has enormous implications for women worldwide, and for our health
system, which annually spends billions of dollars on cervical screening
programs."
Recruitment for a larger, Phase III trial of the vaccine ? the last
step prior to licensing the drug for general use ? is now underway at
Norris Cotton Cancer Center and other sites, Harper said. "We hope these
results will encourage women to sign up for this trial." She noted that
Norris Cotton Cancer Center is the only Northeastern site other than
Philadelphia participating in the large-scale trial, so women from
throughout New England who meet the criteria and are interested are
advised to enroll here. For more information on the trial, email
vaccine@Dartmouth.edu
or call Lisa Matthews at 603-653-3692.
The vaccine discussed in The Lancet article and in the larger trial
now underway is being developed and would ultimately be licensed by
GlaxoSmithKline. Dr. Harper is an independent researcher who acted as
Primary Investigator and is neither paid nor employed by GSK.
Source
Diane M Harper, Eduardo L Franco, Cosette Wheeler, Daron G Ferris,
David Jenkins, Anne Schuind, Toufik Zahaf, Bruce Innis, Paulo Naud,
Newton S De Carvalho, Cecilia M Roteli-Martins, Julio Teixeira, Mark M
Blatter, Abner P Korn, Wim Quint, Gary Dubin, for the GlaxoSmithKline
HPV Vaccine Study Group.* Efficacy of a bivalent L1 virus-like particle
vaccine in prevention of infection with human papillomavirus types 16
and 18 in young women: a randomised controlled trial. Lancet 2004;
364: 1757-65
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