An assessment of the CDC anthrax vaccine safety and efficiacy research program /
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| Format: | Book |
| Language: | English |
| Published: |
Washington, D.C. :
National Academies Press,
[2003]
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| Subjects: |
Table of Contents:
- Executive summary
- Study process
- Overall assessment of the CDC research plan
- Proposed studies on the efficacy of the anthrax vaccine
- Proposed studies on the safety of the anthrax vaccine
- Proposed studies on the acceptability of the anthrax vaccine
- Research gaps
- Bioterrorism and research needs
- A need for a single program leader
- References
- Pt. I. Introduction
- Origin of the study
- Study process and information sources
- Interim report
- Related reports
- Organization of the report
- References
- Pt. II. Background
- Anthrax disease
- Anthrax vaccine
- Immunogenicity and efficacy issues
- Regulatory considerations
- Safety concerns about the anthrax vaccine
- Vaccine adverse event reporting system
- Defense medical surveillance system
- References
- Pt. III. The CDC anthrax vaccine research plan
- Efficacy
- Safety
- Acceptability
- References
- Pt. IV. Proposed studies on the efficacy of the anthrax vaccine
- Objectives and critical research questions for CDC research on the efficacy of he anthrax vaccine
- Anthrax vaccine adsorbed : human reactogenicity and immunogenicity trial to address change in route of administration and dose reduction (human clinical trial)
- Nonhuman primate vaccine dose ranging, immunogenicity, and challenge trial
- Immune correlates of protection against inhalation anthrax studies
- References
- Pt. V. Proposed studies on the safety of the anthrax vaccine
- Objectives and critical research questions for CDC research on the safety of the anthrax vaccine
- Anthrax vaccine adsorbed : human reactogenicity and immunogenicity trial to address change in route of administration and dose reduction
- Follow-up study of textile mill workers vaccinated against anthrax
- Studies based in the vaccine healthcare center network
- Enhanced signal detection and hypothesis testing for adverse events following anthrax vaccination
- Possible role of aluminum hydroxide adjuvant in AVA-associated adverse events
- Reproductive health
- References
- Pt. VI. Proposed studies on the acceptability of the anthrax vaccine
- Objectives and critical research questions for CDC research on the acceptability of the anthrax vaccine
- Survey of knowledge, attitudes, and beliefs regarding the anthrax vaccine among military personnel
- Survey of civilian and military health care providers regarding the anthrax vaccine and the reporting of possible vaccine-associated adverse events
- References
- Pt. VII. Summary assessment of the CDC anthrax vaccine research plan
- CDC research plan
- Bioterrorism and research needs
- A need for a single program leader
- References
- Appendixes : Biographical sketches
- Information-gathering meeting agendas
- CDC anthrax vaccine safety and efficacy research plan
- Food and drug administration final rule : new drug and biological drug products ; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible
- Department of defense memorandum : reintroduction of the anthrax vaccine immunization program
- Institute of medicine : CDC anthrax vaccine safety and efficacy research program : interim report
- Finding and recommendations
- Institute of medicine : the anthrax vaccine : is it safe? does it work? Findings and recommendations