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Vaccine prevents HPV 16-linked CIN 2 and 3: no cases of HPV-related CIN occurred in any vaccine recipient during this 3.5-year study.(News)
WASHINGTON -- An experimental monovalent vaccine against human papillomavirus strain 16 prevents cervical intraepithelial neoplasia grades 2 and 3 in young women, Constance Mao, M.D., reported at the annual Interscience Conference on Antimicrobials and Chemotherapy.
The vaccine's manufacturer, Merck, is now conducting phase III trials of a quadrivalent HPV vaccine containing oncogenic types 16 and 18 as well as condyloma-associated types 6 and 11. Those trials involve more than 25,000 people aged 9-24 years--including a small proportion of males--in 33 countries. The company anticipates filing for U.S. approval of that vaccine by the end of 2005, Eliav Barr, M.D., senior director of biologics and clinical research at Merck, said in an interview.
In the phase II "proof of principle" study, Merck's monovalent HPV 16 L1 virus-like-particle vaccine was 94% effective in preventing persistent HPV 16 infection and 100% effective against cervical intraepithelial neoplasia (CIN) grades 2 and 3, compared with placebo over 3.5 years. The study included 1,533 women aged 16-23 years who were initially negative for both HPV 16 DNA and antibodies.
"It's very exciting," Dr. Mao, an ob.gyn. at the University of Washington, Seattle, said at the meeting, sponsored by the American Society for Microbiology.
An interim report 2 years ago from the phase II trial--conducted at 16 college campus communities in the United States--demonstrated similar efficacy at 17.4 months against persistent HPV 16, but had left undefined the vaccine's impact on CIN 2/3 (N. Engl. J. Med. 2002;347:1645-51).
Doses of the monovalent vaccine or placebo were given at day 0, month 2, and month 6. Genital samples for HPV 16 DNA and Pap smears were done at day 0, month 7, and every 6 months thereafter through 48 months. Anti-HPV 16 serology was done at 6- and 12-month intervals.
The only significant adverse event associated with the vaccine was mild to moderate pain at the injection site, Dr. Barr said.
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Source: HighBeam Research, Vaccine prevents HPV 16-linked CIN 2 and 3: no cases of HPV-related...