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High efficacy is predicted for pair of new human papillomavirus vaccines.(News)

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| June 01, 2006 | McNamara, Damian | COPYRIGHT 2006 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

JACKSONVILLE, FLA. -- Both vaccines to prevent human papillomavirus infection will be highly effective, Dr. Diane M. Harper said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Approximately 600 women participated in efficacy studies for a quadrivalent vaccine (Gardasil, Merck), and another 1,100 participated in efficacy studies for a bivalent vaccine (Cervarix, GlaxoSmithKline).

All women were screened at baseline to ensure seronegativity for high-risk strains 16 and 18 of the human papillomavirus (HPV) as well as for strains 6 and 11, which are also included in the quadrivalent product.

"The response was 100% for the bivalent and 89% for the quadrivalent for persistent, vaccine-specific HPV types for those who got the vaccine on time," Dr. Harper said. The recommended regimen for both vaccines is a 0.5-cc injection at 0, 2, and 6 months. In the studies, 94% of participants received all three doses, although not all according to protocol. The off-schedule efficacy was 95% and 89%, respectively, but these differences were not statistically different. "It indicated these will work in a real-world setting," she added.

Goals of vaccination include reduction of HPV transmission and anogenital lesions, "but most importantly we want to reduce incidence of cervical cancer," said Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center, Lebanon, N.H. She added that prevention of other anogenital cancers may be a serendipitous benefit of the vaccines. Licensure of the quadrivalent vaccine is expected soon, and the bivalent vaccine may be cleared for marketing by the end of this year.

Both vaccines target high-risk HPV type 16, the type primarily implicated in cervical cancer. Type 16, together with types 18 (also in both vaccines), 31, and 45, account for 81% of cervical cancers, Dr. Harper ...

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