CLINICAL TRIAL: A DOUBLE-BLIND, RANDOMIZED, CONTROLLED PHASE III STUDY TO ASSESS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this study is to determine whether gDt-alum-MPL vaccine protects women who are HSV-1 (herpes simplex virus) and HSV-2 negative against genital herpes caused disease caused by either HSV1 or HSV2. The secondary objectives are to (a) determine whether gDt-alum-MPL vaccine prevents HSV-1 and HSV-2 negative women from acquiring HSV1 or HSV2 infection, reduces HSV shedding following HSV-2 seroconversion, reduces the frequency of recurrent genital herpes disease, or prevents oro-labial disease, and (b) to assess potential correlates of immune protection for HSV-2 genital disease and HSV-2 infection.