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Executive Summary
Pages 1-17

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From page 1...
... In .3 AN ASSESSMENT OF THE CDC Anthrax Vaccine Safety and Efficacy Research Program Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program Medical Fo~Iow-up Agency INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C.
From page 2...
... 200-2000-00629~. The views presented in this report are those of the Institute of Medicine Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program and are not necessarily those of the funding agencies.
From page 3...
... ~ICnowin,g is not eno'`~b; we finest apply. Willi''`q is no' enough; we mast dfo.
From page 4...
... THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medirine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters.
From page 5...
... COMMITTEE TO REVIEW THE CDC ANTHRAX VACCINE SAFETY AND EFFICACY RESEARCH PROGRAM PHILIP S BRACHMAN (Chair)
From page 7...
... Preface .
From page 8...
... While reviewing the CDC research program, our committee was alert to the need to address questions concerning the present anthrax vaccine and to consider the contribution that CDC's research might make in support of the evaluation of a newer vaccine. The committee would like to thank staff members from the Centers for Disease Control and Prevention and their collaborators who prepared reports and presentations for the committee and responded to our questions throughout our deliberations.
From page 9...
... Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge.
From page 11...
... Contents EXECUTIVE SUMMARY Study Process, 2 Overall Assessment of the CDC Research Plan, 2 Proposed Studies on the Efficacy of the Anthrax Vaccine, 4 Proposed Studies on the Safety of the Anthrax Vaccine, 5 Proposed Studies on the Acceptability of the Anthrax Vaccine, 8 Research Gaps, 8 Bioterrorism and Research Needs, 9 A Need for a Single Program Leader, 10 References, 16 1 INTRODUCTION Origin of the Study, 18 Study Process and Information Sources, 20 Interim Report, 20 Related Reports, 21 Organization of the Report, 22 References, 22 2 BACKGROUND Anthrax Disease, 24 Anthrax Vaccine, 25 Tmmunogenicity and Efficacy Issues, 26 Regulatory Considerations, 26 Safety Concerns About the Anthrax Vaccine, 27 Vaccine Adverse Event Reporting System, 28 Defense Medical Surveillance System, 29 References, 30 xi 1 18 23
From page 12...
... xii THE CDC ANTHRAX VACCINE RESEARCH PLAN Efficacy, 34 Safety, 39 Acceptability, 41 References, 42 4 PROPOSED STUDIES ON TH1f EFFICACY OF THE ANTHRAX VACCINE Objectives and Critical Research Questions for CDC Research on the Efficacy ofthe Anthrax Vaccine, 43 Anthrax Vaccine Adsorbed: Human Reactogenicity and Immunogenicity Trial to Address Change in Route of Administration and Dose Reduction (Human Clinical Trial) , 45 Nonhuman Primate Vaccine Dose Ranging, Tmmunogenicity, and Challenge Trial, 49 Immune Correlates of Protection Against Inhalational Anthrax Studies, 52 References, 55 PROPOSED STUDIES ON THE SAFETY OF THE ANTHRAX VACCINE Objectives and Critical Research Questions for CDC Research on the Safety of the Anthrax Vaccine, 57 Anthrax Vaccine Adsorbed: Human Reactogenicity and Tmmunogenicity Trial to Address Change in Route of Administration and Dose Reduction, 58 Follow-up Study of Textile Mill Workers Vaccinated Against Anthrax, 63 Studies Based in the Vaccine Healthcare Center Network, 66 Enhanced Signal Detection and Hypothesis Testing for Adverse Events Following Anthrax Vaccination, 73 Possible Role of Aluminum Hydroxide Adjuvant in AVA-Associated Adverse Events, 79 Reproductive Health, 80 References, 80 CONTENTS 33 43 56 6 PROPOSED STUDIES ON THE ACCEPTABILITY OF THE ANTHRAX VACCINE 82 Objectives and Critical Research Questions for CDC Research on the Acceptability ofthe Anthrax Vaccine, 82 Survey of Knowledge, Attitudes, and Beliefs Regarding the Anthrax Vaccine Among Military Personnel' 84 Survey of Civilian and Military Health Care Providers Regarding the Anthrax Vaccine and the Reporting of Possible Vaccine-Associated Adverse Events, 88 References, 89 7 SUMMARY ASSESSMENT OF THE CDC ANTHRAX VACCINE RESEARCH PLAN CDC Research Plan, 91 Biote~rorism and Research Needs, 96 A Need for a Single Program Leader, 97 References, 99 APPENDIXES A Biographical Sketches, 101 B Information-Gathering Meeting Agendas, 105 C CDC Anthrax Vaccine Safety and Efficacy Research Plan, 113 91 I, .
From page 13...
... CONTENTS D 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, 137 E Department of Defense Memorandum Reintroduction of the Anthrax Vaccine Immunization Program, 149 F Institute of Medicine: CDCAnthrauc Vaccine Safety & Efficacy Research Program: Interim Report Findings and Recommendations, 153 G Institute of Medicine: Me Anthrax Vaccine: Is It Safe?
From page 14...
... Figures, Tables' and Boxes FIGURES 6-1 Proposed components and estimated timeline for the KAB survey of military personnel regarding the anthrax vaccine, 85 TABLES ES-1 Additional Research Needs Concerning the Safety and Efficacy of the Anthrax Vaccine, Identified and Prioritized by the Committee, 9 3-l ~ CDC Efficacy Research Questions, 35 3-2 CDC Safety Research Questions, 36 3-3 CDC Acceptability Research Questions, 37 Schedule of Injections for Study Groups in the Human Clinical Trial of Alternative Routes of Vaccine Administration and Schedules of Vaccine Doses, 46 7-1 Committee Prioritization of Studies in the CDC Research Program on the Safety and Efficacy of the Anthrax Vaccine, 93 7-2 Additional Research Needs Concerning the Safety and Efficacy of the Anthrax Vaccine, Identified and Priontized by the Committee, 96 BOXES ES-1 Studies Proposed by CDC for the Anthrax Vaccine Safety and Efficacy Research Program, 3 ES-2 Chapter 4 Findings and Recommendations, 11 ES-3 Chapter 5 Findings and Recommendations, 12 ES-4 Chapter 6 Findings and Recommendations, 15 ES-5 Chapter 7 Findings and Recommendations, 16 1-1 Congressional Request for CDC Anthrax Vaccine Research, FY 2000-1, 19 XtV
From page 15...
... FIGURES, TABLES, AND BOXES 1-2 Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program Statement of Task, 19 CDC Objectives for Research on the Efficacy of the Anthrax Vaccine, 34 CDC Objectives for Research on the Safety of the Anthrax Vaccine, 40 CDC Objectives for Research on the Acceptability ofthe Anthrax Vaccine, 41 4-1 CDC Objectives for Research on the Efficacy of the Anthrax Vaccine, 44 4-2 Critical Research Questions Regarding the Efficacy of the Anthrax Vaccine, as Identified by CDC, 44 4-3 Goals of Assays of Immune Correlates of Protection, as Specified by CDC, 53 5-l 5-2 5-3 xv CDC Objectives for Research on the Safety of the Anthrax Vaccine, 57 Critical Research Questions Regarding the Safety of the Anthrax Vaccine, as Identified by CDC, 57 Categories of Adverse Events to Be Identified During the Human Clinical Trial, 60 6-l CDC Objectives for Research on the Acceptability ofthe Anthrax Vaccine, 83 6-2 Critical Research Questions Regarding the Acceptability of the Anthrax Vaccine, as Identified by CDC, 83 6-3 Specific Aims of the Survey of Knowledge, Attitudes, and Beliefs Regarding the Anthrax Vaccine Among Military Personnel, as Identified by CDC, 84 ,3
From page 16...
... Abbreviations and Acronyms ACIP AM:SA AVA AVIP B anthracis BIDR BMI CAMR CD4+ T cell CDC CFR CMI COSTART DMSS DNA DoD DTP EF ELISA ELISPOT FDA GMC HLA HRQoL Advisory Committee on Immunization Practices Army Medical Surveillance Activity Anthrax Vaccine Adsorbed Anthrax Vaccine Immunization Program Bacillus anthracis balanced inventory of desirable responding Battelle Memorial Institute Centre for Applied Microbiology and Research cluster of differentiation antigen 4 T cell Centers for Disease Control and Prevention Code of Federal Regulations cell-mediated immune response Coding Symbols for Thesaurus of Adverse Reaction Terms Defense Medical Surveillance System deoxyribonucleic acid Department of Defense diphtheria and tetanus toxoids and pertussis vaccine edema factor enzyme-linked immunosorbent assay enzyme-linked immunospot Food and Drug Administration geometric mean concentration human leukocyte antigen health-related quality of life xv'
From page 17...
... pX02 plasmid X02 RTT Research Triangle Tnstitute SF-36 SMR SQ SSA TNA U.S. VAERS VHC VSD Q ,5 XV11 36-item short-form health survey standardized mortality ratio subcutaneous Social Security Administration toxin neutralizing antibody United States Vaccine Adverse Event Reporting System Vaccine Healthcare Center Vaccine Safety Datalink


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