CDC Anthrax Vaccine Safety & Efficacy Research Program Interim Report (2001) / Chapter Skim
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2. Interim Findings and Recommendations
2. Interim Findings and Recommendations
Pages 21-36
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From page 21... ...
policy decision of universal vaccination for troops have been associated with concern among some military personnel and their families. The dissatisfaction couict result from various combinations of factors' including potential for local or systemic adverse events, the number and timing of injections, the perceived risk of exposure to B
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From page 22... ...
In addition, the CDC should continue and complete development of the individual projects in the research program. 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.
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From page 23... ...
several omissions in the set of study plans where the omitted study might be unnecessary for the labeling change but quite important in the wider research context, including future studies of safety and efficacy of products yet to be approved. The primary elements of the CDC research plan uncler the purview of the NIP include studies of the knowledge, attitudes, and beliefs of populations regarding aspects of the anthrax vaccine immunization program (AV1P)
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From page 24... ...
: 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 development or planned for development 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)
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From page 25... ...
The committee recognizes that the human clinical trials are intended to investigate gentler differences related to adverse reactions, as specifically mentioner! in the Congressional mandate.
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From page 26... ...
. The committee recommends that the CDC consider, in addition to the proposed clinical trial, a prospectively (lesigne(l pharmacoepi(lemiologic stiffly of military vaccine recipients with both active surveillance and historical data from DMSS for moderate to 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.
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From page 27... ...
. The committee recommends that the CDC consider including additional items with the SF-36 specific to adverse events possibly associated with immunization, and clearly indicate how the use of the SF-36 will be included in the protocol.
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From page 28... ...
The committee did not make additional recommendations on the challenge study, but urges, as in the case of the human clinical trial, careful consideration at the outset of appropriate methods of statistical analysis. Part C: Assays of Immunologic Correlates of Protection Part C is related to both Parts A and B above.
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From page 29... ...
applied to anthrax vaccine recipients. The CDC also plans two substudies in association with the Human Clinical Trial or Part A
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From page 30... ...
This study, which has not yet begun, will be designed to describe the KAB of military service personnel in general and also of military health care providers regarding immunization against anthrax. The resulting descriptive information will, it is hoped, provide the basis to assess the reasons for concern about anthrax vaccination and the eclucational needs pertaining to the anthrax vaccinations of the populations stuclied.
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From page 31... ...
1 Time passes; educational inter ventions and other events occur that ~ could affect KAB Longitudinal Longitudinal Cohort Cohort KAB AT BASELINE KAB AT FOLLOW-UP Figure 2-l KAB Survey of Military Personnel Regarding the Anthrax Vaccine . The committee recommends that the CDC consider expan[ling the (resign phase of the KAB study of military personnel regarding the anthrax vaccine 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, in order to refine the sampling plan.
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From page 32... ...
The committee heard testimony from some concerned service members and other citizens indicating that they believe that the anthrax vaccine may be associated with more adverse events than reflected in VAERS, due at least in part to aspects of military life that may tend to discourage the reporting of adverse events. Based on the information available at the time of this report, the KAB study of health care providers with respect to VAERS reporting seems to be directed primarily toward investigating that concern, that is, toward enhancing VAERS reporting, especially in the military.
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From page 33... ...
The committee commented that data from the DMSS, which tracks the medical encounters and other pertinent data on military personnel, offers such an independent comparison at least for moderate and severe adverse events, and noted farther that this is an example of an area of potential collaboration between the CDC and the DoD. Furthermore, the committee found that the survey of military vaccine providers regarding VAERS might be coupled with the segment of the survey regarding the stance of health care providers toward the anthrax vaccine, as mentioned above.
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From page 34... ...
Finally, the CDC is pursuing several hybrid approaches such as using factor analysis anct logistic regression to attempt to reduce the number of variables that could possibly be relevant through the identification of structure underlying adverse events, then developing a logistic mode! to predict from those factors which vaccine had been given.
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From page 35... ...
illustration of potential relationships between the set of adverse events actually causer! by the product itself (labeled "true")
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From page 36... ...
The committee looks forward to receiving further information and protocols as the CDC continues to develop its overall anthrax vaccine safety and efficacy research program.
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