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HPV vaccine may be effective in fewer than three doses

Kreimer AR. J Natl Cancer Inst. 2011;doi:10.1093/jnci/djr319.

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One and two doses of the HPV 16/18 vaccine were as beneficial as the three-dose regimen 4 years after vaccination, according to data from a recent study.

Aimee R. Kreimer, PhD, of the division of cancer epidemiology and genetics at the National Cancer Institute, NIH, and colleagues used data from the NCI-sponsored Costa Rica Vaccine Trial to determine whether a lower number of doses of the bivalent HPV vaccine (Cervarix, GlaxoSmithKline) were effective. Women in the trial (n=7,466) received either three doses of the vaccine or a control vaccine.

Twenty percent of the women enrolled received fewer than three doses of the vaccine because of factors such as pregnancy and referrals for colposcopy during routine management. During 4 years of follow-up, Kreimer and colleagues compared the frequency of persistent HPV 16 or HPV 18 infection in the HPV and control arms among those who received one or two doses of the vaccine and in women who received all three doses. Women with no follow-up or who were HPV 16 and HPV 18 DNA-positive at the time of enrollment were excluded, resulting in 5,967 women who received three doses, 802 who received two doses and 384 who received one dose.

The level of protection was similar among women receiving one, two and three doses of the vaccine, according to the researchers. Efficacy rates were: 80.9% for three doses (95% CI, 71.1-87.7), 84.1% for two doses (95% CI, 50.2-96.3) and 100% for one dose (95% CI, 66.5-100).

“Our clinical efficacy data provide suggestive evidence that an HPV vaccine program that provides fewer doses to more women could potentially reduce cervical cancer incidence more than a standard three-dose program that uses the same total number of doses but in fewer women,” the researchers wrote.

In an accompanying editorial, Cosette Marie Wheeler, PhD, of the department of pathology and department of obstetrics and gynecology at the University of New Mexico, said there is a need for additional, larger studies specifically designed to analyze the efficacy of one, two and three doses of the vaccine for adolescent girls. Due to the high cost of clinical trials, however, phase 4 efficacy studies and population-based surveillance programs may be useful.

“The age-old adage of less is more may apply to HPV vaccination, and if so, the report of Kreimer et al represents an important step on the road to more effective and sustainable cervical cancer prevention programs,” Wheeler said.

This is an important analysis as it strongly suggests that a simpler and more cost-effective approach to HPV vaccination may provide equivalent protection to the approved three-dose vaccination strategy. Before use of a two or even a single vaccination becomes accepted as a routine strategy it will be critical for confirmation of these study findings to be provided through analysis of one (or more) of several other HPV vaccination studies that have previously reported results utilizing a three-dose approach.

Maurie Markman, MD
HemOnc Today Editorial Board member

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