Bivalent HPV Vaccine Highly Effective Against CIN2+

Last Updated: 2009-07-06 18:30:28 -0400 (Reuters Health)

NEW YORK (Reuters Health) - The human papillomavirus (HPV)-16/18 AS04-advjuanted vaccine offers strong protection against cervical intraepithelial neoplasia (CIN) 2+, according to the final analysis of data from the Papilloma TRIal against Cancer In young Adults (PATRICIA).

"The HPV-16/18 AS04-adjuvanted vaccine provided protection against CIN2+ lesions that were associated with HPV-16 and HPV-18 as well as lesions that were associated with non-vaccine types HPV-31, HPV-33, and HPV-45; together, these five types are responsible for about 82% of all cervical cancers," Dr. J. Paavonen, from the University of Helsinki, and colleagues conclude.

As reported in the July 7th online issue of The Lancet, PATRICIA involved 18,644 women, 15 to 25 years of age, who were randomized to receive the HPV vaccine or a hepatitis A control vaccine at 0, 1, and 6 months. The average follow-up period after the last dose was 34.9 months.

In the primary analysis, the HPV vaccine was 92.9% effective in preventing HPV-16/18-related CIN2+. In an analysis in which likely causality to HPV type was assigned in lesions harboring several oncogenic types, the efficacy was 98.1%.

In all subjects vaccinated, the HPV vaccine was 30.4% effective against CIN2+ irrespective of HPV DNA in lesions. In women with no evidence of oncogenic HPV infection at baseline, vaccine was 70.2% effective. Corresponding efficacy rates for CIN3+ were 33.4% and 87.0%.

The HPV vaccine was 54.0% effective in protecting against CIN2+ associated with 12 non-vaccine oncogenic HPV types, the researchers note.

In an accompanying editorial, Dr. Karin B. Michels and Dr. Harald zur Hausen, from Harvard Medical School, Boston, write that for the HPV vaccine to be a truly effective public health intervention, it must be also be given to boys and men.

"Currently, the targets for HPV vaccination are girls and young women aged 11 to 26 years before sexual debut," they note. "Although good use of the programme will reduce cervical cancer incidence in a couple of decades, this subgroup of the population at risk is too small to limit the spread of the virus. The only efficient way to stop the virus is to also vaccinate the other half of the sexually active population: boys and men."

Source:

Lancet 2009.


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