Most Women Up to 45 Years Could Benefit From Human Papillomavirus Vaccination: Presented at SGO
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Most Women Up to 45 Years Could Benefit From Human Papillomavirus Vaccination: Presented at SGO

By Ed Susman

TAMPA, Fla -- March 14, 2008 -- Most women -- even those aged more than 26 years and who have had multiple sexual partners -- could benefit from the vaccine that protects against quadrivalent human papillomavirus (HPV) types 6, 11, 16 and 18, the pathogens that cause most cervical cancers and genital warts.

Two-thirds of women aged between 24 and 45 years were naive to HPV 6, 11, 16, and 18 at enrolment, as determined by serology and DNA testing, according to a study presented here at the Society of Gynecologic Oncologists (SGO) 2008 Annual Meeting on Women's Cancer.

Investigator Sharmila Makhija, MD, Associate Professor of Gynecologic Oncology, University of Alabama, Birmingham, Alabama, presented the study findings on March 11.

"These women between the ages of 24 and 45 may therefore benefit from the quadrivalent vaccine," she said in her oral presentation.

Dr. Makhija said that 92% of women were infected by 1 of the 4 types of the virus covered by the vaccine, suggesting that these women also could receive at least partial protection from the vaccine. Only 0.4% of women were determined to have infection with all 4 types of HPV covered by the vaccine.

The study enrolled 3,817 women aged 24 to 45 years. Exclusion criteria were previous loop electrosurgical excision procedures for suspected abnormal cervical lesions, hysterectomy, history of cervical biopsy in the previous 5 years, and history of genital warts. There was no limit on the number of lifetime sexual partners.

The women underwent Papanikolaou tests at baseline and about every 6 months for 48 months. DNA and serology testing were performed to detect current or past HPV infection.

In the primary efficacy measure of persistent infection with any of the 4 HPV types or any cervical, vulvar, or vaginal disease, researchers reported 4 cases among the 1,911 women who received the active vaccine and 41 cases among the 1,908 women given the placebo vaccine. This represented a 91% efficacy of the vaccine and was highly statistically significant (P < .001), Dr. Makhija said.

Funding for this trial was provided by Merck & Co.

[Presentation title: Baseline Type Seropositivity and DNA Positivity of Women Aged 24-45 Participating in a Phase III Clinical Trial of Quadrivalent HPV (Type 6/11/16/18) L1 VLP Vaccine. Abstract LB2]

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