Editorial

Given the morbidity and treatment challenges posed by many disease states, prevention of these conditions would clearly be a preferable alternative. Over the past year, we have observed examples of progress in this direction, especially in the field of infectious diseases. The two most recent prevention strategies have been introduced this year. In October 2005, Merck announced that an investigational vaccine (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) prevented 100 precent of high-grade cervical pre-cancers and non-invasive cervical cancers associated with human papillomavirus (HPV) types 16 and 18 in a recent phase III study (P<0.001) [1]. The analysis compared the vaccine to placebo in women who were not infected with HPV 16 and 18 at enrollment and who remained free of infection through the completion of the vaccination regimen. Women were followed for an average of two years after enrollment. This phase III study was a prospective, randomized, double-blind, placebo-controlled study with two vaccination groups. Women aged 16 to 26 years were randomized to receive a three-dose regimen of either vaccine or placebo at Day 1, Month 2, and Month 6. A total of 12,167 women were enrolled from 90 study centers worldwide. The most common vaccine-related adverse event reported was local discomfort at the injection site [1]. Of particular interest to dermatologists, this HPV vaccine demonstrated 100 percent efficacy in preventing genital warts, vaginal dysplasia, and vulvar dysplasia in another study (P<0.001) [2]. In this trial, 2261 sexually active women aged 16 to 23 received 1 inoculation with vaccine and then received additional vaccinations at 1 and 6 months. A similar group of 2279 agematched women received placebo vaccinations on the same schedule. The investigators determined that, of the women who were vaccinated according to the protocol, none developed genital warts, or high-grade vulvar or vaginal dysplasia. Forty cases (1.8%) of genital warts or precancerous lesions occurred in the placebo group [2]. This vaccine was approved in the United States in June 2006. Herpes zoster is another disease for which a new vaccine has been developed. The incidence and severity of this condition and and the associated postherpetic neuralgia increases with age, and we have an increasingly aging population. Oxman et al. [3] conducted a large study in order to determine if vaccination against varicella zoster virus (VZV) would decrease the incidence, severity, or both of herpes zoster and postherpetic neuralgia among older adults. They enrolled 38,546 adults 60 years of age or older in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated Oka/Merck VZV vaccine (“zoster vaccine”). The pain and discomfort associated with herpes zoster were measured repeatedly for six months. The primary end point was the burden of illness due to herpes zoster, a measure affected by the incidence, severity, and duration of the associated pain and discomfort. The secondary end point was the incidence of postherpetic neuralgia. More than 95 percent of the subjects continued in the study to its completion, with a median of 3.12 years of surveillance for herpes zoster. The use of the zoster vaccine reduced the burden of illness due to herpes zoster by 61.1 percent (P<0.001), reduced the incidence of postherpetic neuralgia by 66.5 percent (P<0.001), and reduced the incidence of herpes zoster by 51.3 percent (P<0.001) [3]. Reactions at the injection site were more frequent among vaccine recipients but were generally mild. The zoster vaccine was approved in May 2006, for prevention of herpes zoster in individuals 60 years of age and older. The application of vaccines represents a new and exciting paradigm in the treatment of dermatologic disease. The HPV and zoster vaccines will offer us assistance in treating two very challenging conditions, and offer our patients with these conditions the potential for improved quality of life. Disclosure: Dr. Weinberg is a member of the Speakers' Bureau for Merck. References [1] http://www.brightsurf.com/news/headlines/view.article.php?ArticleID=21282. Accessed November 19, 2006. [2] http://www.docguide.com/news/content.nsf/news/8525697700573E18852570DC0054023E. Accessed November 19, 2006. [3] Oxman MN, Levin MJ, Johnson GR, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005; 352: 2271-2284.