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Quadrivalent HPV vaccine effective in women aged 24 to 45 years

Issue: July 2009

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The human papillomavirus vaccine for types 6, 11, 16 and 18 was effective in more than 90% of women aged 24 to 45 years who were not already infected with the studied disease types at enrollment.

Researchers conducted a trial from 2004 to 2005 at several sites in Bogota, Colombia.

They randomly assigned 1,911 women to receive a dose of the quadrivalent human papillomavirus (HPV) vaccine at day one, month two and month six and 1,907 women to receive placebo using the same schedule.

There were two primary endpoints: duration of infection of more than six months and cervical and external HPV disease due to types 6, 11, 16 or 18, or due to types 16 and 18 only.

In the per-protocol population, the vaccine demonstrated efficacy against disease or infections related to all four types of HPV in 90.5% of women (95% CI, 73.7-97.5). The vaccine was effective in 83.1% of women with disease or infections related to types 16 and 18 (95% CI, 50.6-95.8).

The researchers also calculated intention-to-treat results in women who had infections at baseline. The vaccine demonstrated that the vaccine was effective against 30.9% of disease or infections caused by all four types (95% CI, 11.1-46.5) and was effective 22.6% of the time in women with infections caused by types 16 and 18 (95% CI, –2.9-41.9).

The researchers reported no adverse events related to the vaccine.

Munoz N et al. Lancet. 2009; 373:1949-1957.

This is an important paper as the data clearly confirm the favorable immunogenicity and potential efficacy of HPV vaccination in an older female population (24-45 years of age) than the participants in the previously published paradigm-changing studies in this arena. Further, these results support the rational argument that this older female population should also be considered for routine vaccination if known to not have previously been exposed to HPV. Specifically, this might include women whose first sexual experience occurred somewhat later in life, for example after the age of 24.

– Maurie Markman, MD

University of Texas MD Anderson Cancer Center