Skip to main content

Currently Skimming:

4 Proposed Studies on the Efficacy of the Anthrax Vaccine
Pages 43-55

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 43...
... The disease had become extremely uncommon in any form in the United States until the intentional distribution of anthrax spores through the postal system in the fall of 2001. These bioterrorist events led to 11 cases of inhalational anthrax, 5 of which were fatal, and to ~ confirmed and 4 suspected cutaneous anthrax infections (CDC, 2001b, 2002~.
From page 44...
... anthracis is very hardy anthrax spores can lie dormant in soil for many years and are resistant to physical and chemical challenges such as heat, Slyness, and disinfectants. As noted, depending on the site of anthrax infection, disease can occur in three forms: cutaneous, gastrointestinal, or inhalational anthrax.
From page 45...
... (Pittman, 2002~. Taking into account these pilot data, CDC proposes two hypotheses related to immunogenicity for the Human Clinical Trial: I
From page 46...
... To estimate the effects of genetic variation across the class ~ and class ~ HLA alleles and the immune response (circulating antibody level and anthrax-specific lymphoproliferative responses) following anthrax immunization in human subjects (CDC, 2002h, pp.
From page 47...
... Finding: As described in the study protocol, the human clinical trial is generally responsive to the congressional mandate and to important research needs for determining immunologic s According-to-protocol analysis includes in its calculations only those study participants who fulfill all entry criteria and complete the trial according to its protocol. Tent-to-treat analysis includes data from all study participants regardless of whether every person enrolled or randomly assigned to a group completed the trial.
From page 48...
... There is good evidence that immune response is directed in part by genetic background, but large sample sizes are usually needed to associate differences in response with differences in genetic characteristics. The substudy appears adequately powered to address its specific aims of estimating the association between specific alleles of class ~ or IT HLA alleles and the immune response to AVA or of estimating the associations between genetic variation across class ~ and class ~ alleles and changes in the immune response.
From page 49...
... Using dilutions of AVA to induce a spectrum of immune responses, identify immune correlates of protection against challenge at 12, 30, and 42 months after initial immunization of rhesus macaques (Macaca mulatta)
From page 50...
... The laboratory assays for this study as well as those for the human clinical trial and the study of immune correlates of protection have all been reviewed by the Laboratory Issues panel, one of the expert consultation panels convened by CDC in response to recommendations Tom this committee in the interim report. Committee Comments As described in the summaries and research protocols provided to the committee, the NHP study is an appropriate and crucial aspect of the congressionally mandated research to document the efficacy of AVA and to determine immune correlates of protection.
From page 51...
... Although CDC cites identifying the level of circulating antibody required to protect an unvaccinated macaque from anthrax as a critical research question, it assigns the question a low priority. The committee, however, considers passive protection studies to be an essential component of a research program on AVA.
From page 52...
... , neutralization of anthrax lethal toxin at different stages in the anthrax toxin complex formation and the ability of anti-AVA antiserum to promote opsonophagocytosis. To learn as much as possible about the wider immunologic response to AVA, the ICE studies will also include an analysis of factors related to cellular immune response.
From page 53...
... Similarly, there is no clear plan for correlating the count of bone marrow plasma cells to anamnestic immune re
From page 54...
... Investigators at Emory also plan to carry out lymph node biopsies, bone marrow biopsies, and bronchoalveolar barrage on the 33 rhesus macaques housed there. The researchers hope to use the results of those tests to correlate immune responses occurring in tissues or organs of the macaques with their PBMC and to infer the type and magnitude of immune responses to AVA that are occurring systemically in human vaccinees (CDC, 2002c)
From page 55...
... vaccine dose ranging, i~nunogenicity and challenge trial. Anthrax Vaccine Safety and Efficacy Plan.


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.