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An HPV Vaccine -- At Last!

A vaccine against HPV-16 was found to be effective and safe in a randomized clinical trial.

Infection with human papillomavirus (HPV) is a major risk factor for preinvasive and invasive cervical cancer. In this randomized, multicenter, industry-sponsored clinical trial, researchers evaluated a vaccine against HPV type 16, which is present in half of all cases of invasive cervical cancer and high-grade intraepithelial lesions. Subjects were nonpregnant women aged 16 to 23 with no prior abnormal Pap smears and no more than 5 lifetime male sex partners. After initial evaluation, including cervical cytology and HPV assessment, the women received intramuscular injections of vaccine or placebo at day 0, month 2, and month 6 of the study. Participants were followed for 4 years after the third injection.

A total of 1533 women (median age, 20; about three quarters were white) were eligible for the primary analysis. Forty-one cases of persistent HPV-16 infection occurred in the placebo group and none in the vaccine group (P<0.001). No serious adverse events related to vaccine administration were noted; pain at the injection site was reported by approximately 85% of women in both groups. Forty-four cases of preinvasive cervical neoplasia not associated with HPV-16 infection were identified -- 22 in each group.

Comment: Because of its potential to reduce preinvasive and invasive genital cancers, the development of what appears to be a safe, effective vaccine against HPV-16 represents a major step forward in women's (and men's) health. The most appropriate target population for an HPV vaccine might be teenagers who have not yet initiated sexual activity. Unfortunately, this vaccine does not protect against other sexually transmitted oncogenic HPV types.

One can anticipate a number of challenges to widespread use of such a vaccine: In the U.S., where the federal government supports vaccination of children, will there be political obstacles to funding a vaccine that makes sex safer? Given that the main beneficiaries of an HPV vaccine will be women, will parents of teen boys balk at having their sons vaccinated? In less developed countries where invasive cervical cancer is most prevalent, will cost considerations and the need for 3 injections limit vaccine use?

— Andrew M. Kaunitz, MD

Published in Journal Watch Women's Health January 8, 2003

Citation(s):

Koutsky LA et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med 2002 Nov 21; 347:1645-51.

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• Medline abstract (Free)

Crum CP. The beginning of the end for cervical cancer? N Engl J Med 2002 Nov 21; 347:1703-5.

• Original article (Subscription may be required)
• Medline abstract (Free)