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Herpes Vaccine Test Runs into Recruiting Hurdle
  Chicago Sun-Times
Lori Rackl
It is estimated that one in five Americans over age 12 areinfected with herpes simplex type 2, the virus that causes mostcases of genital herpes. In small trials, a new vaccine byGlaxoSmithKline Biologicals (GSKB) showed promise of preventingthe virus' spread to women but not to men. Researchers haveundertaken a massive clinical trial of the vaccine, and they hadhoped to enroll 7,500 women by summer's end. So far, however, only1,400 have signed up.
"I think we underestimated how hard it would be," said Dr.Judy Falloon, medical monitor for the trial and a physician withthe National Institutes of Health, which is conducting the studywith GSKB.
Problems with recruitment are twofold. One challenge isconvincing potential participants they will not get herpes fromthe vaccine. But a bigger obstacle is finding women ages 18-30 whoare not infected by either herpes simplex type 2 or type 1, thevirus responsible for the cold sores and fever blisters associatedwith oral herpes. Herpes simplex type 1 infects 50-80 percent ofAmericans. So far, almost 5,000 potential participants have beenruled out by screening.
In hopes of boosting enrollment, researchers have expandedthe study beyond its 17 original sites. The University ofIllinois-Chicago (UIC) is a recent addition. The school has signedup 36 women so far, said Dr. Richard Novak, professor ofinfectious diseases at UIC College of Medicine. While the low rateof enrollment will not doom the trial, Novak said, researcherswill have to wait longer for the results.
Women in the study are randomly assigned to receive threeinjections of either the herpes vaccine or the hepatitis Avaccine.
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