• Fierer, Daniel D.S (PI)

Project Details


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. Hypothesis: ACAM3000 smallpox vaccine has a highly favorable safety profile compared with the traditional smallpox vaccine and elicits an adequate immunological response to expect that it will be effective in preventing smallpox. Modified Vaccinia Ankara (MVA) is a strain of vaccinia that has been attenuated by serial passage in chick embryo fibroblasts (CEFs) and is essentially non-replicating in humans. It is believed, therefore, that MVA vaccine may provide effective protection against smallpox without the reactivity and severe side effects associated with replication-competent vaccinia vaccines. A vaccine based on MVA was tested in approximately 120,000 persons in Germany in the 1970s, and was licensed by the German national control authority for use as a pre-vaccination, to be followed by traditional vaccinia vaccine. The ACAM3000 MVA smallpox vaccine, which has a common origin with the German vaccine was subsequently developed in the US at the NIH by further passaging. The Phase 1 study in which 88 vaccination-nanve subjects were vaccinated with ACAM3000 MVA smallpox vaccine was completed in February 2005; there were no serious adverse effects reported, and 97% of the subjects seroconverted after 2 vaccine doses in the highest dose group (1+108 TCID50). No subjects in this study had been previously vaccinated against smallpox, however, and as a large proportion of the population in the US and world-wide has been previously vaccinated against smallpox, it is important to know the safety profile and immunogenicity of the vaccine in this population as well. This Phase II study is therefore designed to confirm the findings of the Phase I trial, further assessing the safety, tolerability, and immunogenicity of ACAM3000 in healthy vaccination-nanve subjects, and to extend the findings in healthy subjects previously vaccinated against smallpox.
Effective start/end date17/04/0628/02/07


  • National Center for Research Resources: $3,753.00


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