ATN 024: A RANDOMIZED, OPEN-LABEL TRIAL OF THREE HEPATITIS B VACCINATION

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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. A multicenter, stratified, block-randomization, open-label trial to study the initial and persistant immune response to and safety of three hepatitis B vaccination schemas in HIV-infected adolescents 12 to < 25 years of age. The randomization will be balcnced with regard to CD4+T cell count of < 500 vs. > or equal to 500 cells/mL and no previous vs. one previous hepatitis B vaccination. Within each of the four strata, the subjects will be randomized so that at the end of each 6-subjects, exactly 2 subjects will have been selected to each of the three arms. The randomization will be restricted so that the percentage of subjects with CD4+ T cell count < or equal to 200 cells/mL will not exceed 15% of subjects on each arm.