A PHASE I/II OF LC16M8, A MODIFIED VACCINIA VACCINE IN HEALTHY VOLUNTEERS

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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. LC16m8 vaccine is being studied for possible licensure in the United States (US) as a potentially safer alternative to the currently licensed Dryvax vaccinia vaccine for protection against smallpox, vaccinia, and related Orthopoxviruses. A total of 45 healthy vaccinia-naive volunteers will be enrolled at Stanford, ranging in age from 18-33 years-old and who fulfill the screening and inclusion/exclusion criteria. Volunteers will be randomized into 2 groups: three fourths of the individuals receiving LC16m8 and one fourth of the individuals receiving the Dryvax strain of vaccinia. The objectives of the study will be the: Assessment of safety, clinical responses, and immunogenicity following vaccination with the LC16m8 vaccine or Dryvax vaccine in healthy vaccinia-naive volunteers.