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HPV vaccine can prevent early in situ cervical ca: prevents CIN2, CIN3 related to HPV 16, 18.(News)
SAN FRANCISCO -- A multinational study of 11,502 young women showed for the first time that a vaccine for human papillomavirus can prevent precancerous cervical lesions and early in situ cervical cancers, Laura A. Koutsky, Ph.D., reported.
The recombinant vaccine against HPV types 6, 11, 16, and 18 was 100% effective in preventing cervical intraepithelial neoplasia (CIN) grades 2 and 3 and adenocarcinoma in situ (AIS) related to HPV 16 or 18 in 5,301 women who completed a three-shot vaccination regimen and were negative for the HPV types at the start and end of vaccinations. HPV 16 and 18 cause approximately 70% of invasive cervical cancers worldwide.
Among 5,258 females who received three placebo shots, 1 developed AIS, 15 developed CIN3, and 5 developed CIN2 during an average 17-month follow-up, Dr. Koutsky said at the annual meeting of the Infectious Diseases Society of America.
The data came from a planned interim analysis of the ongoing Females United to Unilaterally Reduce Endo-Ectocervical Disease study (FUTURE II), a randomized, double-blind, phase III clinical trial of the vaccine made by Merck & Co., said Dr. Koutsky, professor of epidemiology at the University of Washington, Seattle. Dr. Koutsky has received grants and research funding from Merck, which funded the trial.
By year's end, the company plans to apply for approval to market the vaccine under the trade name Gardasil.
A secondary analysis intended to reflect more real-world conditions found the vaccine was 97% effective in preventing CIN2/CIN3 and AIS in women who received at least one of the three intended vaccinations. In this secondary analysis, 1 of 5,736 women in the vaccine group became infected with HPV 16 and developed CIN2. Among 5,766 women in the placebo group, 4 developed AIS, 23 developed CIN3, and 9 developed CIN2 related to HPV 16 or 18 over a 2-year follow-up starting 30 days after the first vaccination.
CIN2/CIN3 and AIS are accepted as surrogates for invasive cervical cancer for research purposes by regulatory agencies.
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Source: HighBeam Research, HPV vaccine can prevent early in situ cervical ca: prevents CIN2,...