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Executive Summary
Pages 1-10

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From page 1...
... On the other hand, the anthrax vaccine and the AV] P have been subject to an unusual degree of concern from some service personnel and their families regarding possible adverse events associated with vaccination.
From page 2...
... The CDC should consider engaging protocol design consultants representing broad scientific expertise who would provide immediate and direct consultation on specific technical matters of study design and execution. The CDC should continue and strengthen collaboration with DoD and NIH wherever possible, including for example much more extensive use of DoD databases such as the Defense Medical Surveillance System (DMSS)
From page 3...
... : A human reactogenicity and immunogenicity trial to address change in route of administration and dose reduction Part B: Non-human primate AVA dose-ranging, immunogenicity and challenge trial Part C: Anthrax pathogenesis, immunology, and correlates of protection against inhalational anthrax Human leukocyte antigen sub-study NIP - in clevelopment or planned for cleve~opment Survey of knowledge, attitudes and beliefs (KAB) prevalent among military service personnel and also of military health care providers regarding the anthrax vaccine Survey of the KAB prevalent among military health care providers regarding practices of reporting to Vaccine Adverse Event Reporting System (VAERS)
From page 4...
... C CDC requested that IOM review the CDC research plan ~ , IOM Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program Meetings to date: October 31, 2000 February 8-9, 2001 April 18-19, 2001 1 Interim Report due June 2001 , ~ Final Report due August 2002 FIGURE ~ Origins of TOM Activities Related to the Anthrax Vaccine PROJECT-SPECIFIC FINDINGS AND RECOMMENDATIONS NCID-Directefd Projects in the Research Program The NCID research plans include a human clinical trial to evaluate changing the route of injection of the licensed vaccine AVA from subcutaneous to intramuscular, and reducing the total number of injections. The results of this work may be used to support a labeling change for the licensed product.
From page 5...
... The committee notes also that the human clinical trials are intended to investigate gentler differences relater} to Diverse reactions, specifically mentioned in the Congressional mandate. Previous work (Pittman et al., submitted for publication)
From page 6...
... that supporting animal studies are of great importance in an anthrax vaccine safety and efficacy research program. It is not possible to do a human clinical trial of vaccine efficacy for inhalational anthrax: the disease has a high fatality rate, and improved working conditions in goat hair anti woolen mills, ant!
From page 7...
... . The committee recommends that the CDC consider both the addition of a passive antibody transfer study, an(l that the animal trial (lose-ranging study design include a more gradual dilution series.
From page 8...
... Survey of knowledge, attitudes, and beliefs of military vaccinee providers about VEERS reporting The national passive surveillance system for medical events occurring after administration of United States licensed vaccines is called the Vaccine Adverse Event Reporting System (VAERS)
From page 9...
... study of military vaccine providers regarding the Vaccine Adverse Event Reporting System (VAERS) reporting to include cognitive and psychometric tests and a pilot survey, in order to design both the educational interventions and the survey that will relate to them and possibly recluce the number of subjects.
From page 10...
... The committee recommends that the CDC consider, in addition to the proposed clinical trial, prospectively designed pharmacoepidemiologic study of military vaccine recipients with both active surveillance and historical data from DMSS for moderate and severe adverse events in order to assess sex or gender and perhaps other risk factors for adverse events among military personnel receiving the anthrax vaccine. The committee recommends that the CDC consider both the addition of a passive antibody transfer study, and that the animal trial dose ranging study design include a more gradual dilution ser~es.


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