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APPENDIX 29
Questions Posed to Outside Experts and List of Responders

If possible, please list references for specific estimates.

1. What is your estimate of overall and age-specific incidence (rate or cases per year)?

OR

What is your estimated incidence of clinical disease, subclinical infection, latent infection, and chronic infection?

2. Is the incidence of the disease changing? In what manner and why?

3. What groups are at greatest risk of illness (e.g., by age, sex, ethnicity, socioeconomic status, immunologic competence, geographic area)?

4. What are specific risk factors for this illness?

5. Please describe typical patterns for the clinical course of this illness, inclu-ding variations in presentation, variations of patterns and severity, complications, case fatality, relapses and sequelae, duration of stages of illness and sequelae, and proportion of cases following each course.

6. Please describe typical forms of care and estimate their effectiveness and cost.

7. What strategies are currently available to prevent this condition (e.g., vector control, treatment of water supply, reduction of behavioral risks [IV drug use, unprotected sexual contact], etc.)?



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Vaccines for the 21st Century: A Tool for Decisionmaking APPENDIX 29 Questions Posed to Outside Experts and List of Responders If possible, please list references for specific estimates. 1. What is your estimate of overall and age-specific incidence (rate or cases per year)? OR What is your estimated incidence of clinical disease, subclinical infection, latent infection, and chronic infection? 2. Is the incidence of the disease changing? In what manner and why? 3. What groups are at greatest risk of illness (e.g., by age, sex, ethnicity, socioeconomic status, immunologic competence, geographic area)? 4. What are specific risk factors for this illness? 5. Please describe typical patterns for the clinical course of this illness, inclu-ding variations in presentation, variations of patterns and severity, complications, case fatality, relapses and sequelae, duration of stages of illness and sequelae, and proportion of cases following each course. 6. Please describe typical forms of care and estimate their effectiveness and cost. 7. What strategies are currently available to prevent this condition (e.g., vector control, treatment of water supply, reduction of behavioral risks [IV drug use, unprotected sexual contact], etc.)?

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Vaccines for the 21st Century: A Tool for Decisionmaking 8. How would you compare these strategies in terms of effectiveness, cost, and practicality to a likely vaccine? 9. What are the known components of immunity for this organism (antibody to what antigens, T-cells, B-cells, etc.)? 10. What are the critical determinants of an immune response associated with protection against infection? 11. What are the correlates of immunity (e.g., surrogates for protection) that may be useful or necessary for vaccine development? 12. To your knowledge, is vaccine development for this disease occurring now? If so, describe the type of vaccine (what antigen, live or killed, subunit, naked DNA, etc.). 13. Who (individual, group, company) is working on this vaccine? 14. How far has vaccine development progressed (preclinical, clinical trials: Phase I, II, or III)? 15. When could Phase III trials be expected to start for such a vaccine? 16. When could such a vaccine be expected to be licensed for use? 17. If a vaccine is not in development, what new knowledge is necessary to undertake vaccine development? 18. Who should develop it (e.g., industry, government, military)? 19. What are the barriers to success in developing a vaccine (money for research, scientific knowledge, correlates of immunity, lack of animal model, public perceptions, etc.)? 20. Please estimate future R&D funding (public and private) needed to achieve licensure of a vaccine and postmarketing costs. 21. Is this vaccine likely to be part of a combination vaccine (with other antigens)? 22. For an anticipated vaccine, please estimate its likely efficacy, likely cost per dose, and number of doses needed for complete immunization (initial series, frequency of boosters).

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Vaccines for the 21st Century: A Tool for Decisionmaking 23. What would be the appropriate target population for a vaccine (e.g., all infants, adolescents, pregnant women, older adults [age 65+], residents of an endemic area)? 24. What would be the anticipated time interval between vaccination of an individual in the target population and the realization by that individual of the health benefits? 25. What would be the anticipated time interval between vaccination in a target population and realizing health benefits to unvaccinated individuals from “herd immunity”? 26. Would delivery of this vaccine incur special costs (e.g., form of administra-tion, education for providers or the public, etc.)? If so, please identify and esti-mate those costs. 27. What factors could be expected to influence acceptance of the vaccine? 28. If possible, please identify recent key articles on this condition/ organism or on development of a vaccine against it that you think represent the best current thinking. 29. If there is a recently published article with which you particularly disagree, please identify and explain. 30. Please identify any other experts who should be consulted. LIST OF RESPONDERS Ann M.Arvin, M.D. Department of Pediatric Infectious Diseases School of Medicine Stanford University Palo Alto, CA Robert Baughn, Ph.D. VA Medical Center Houston, TX Robert B.Belshe, M.D. Department of Infectious Diseases St. Louis University School of Medicine St. Louis, MO Robert Betts, M.D. University of Rochester Rochester, NY

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Vaccines for the 21st Century: A Tool for Decisionmaking Dr. Martin J.Blaser Division of Infectious Diseases Vanderbilt University, School of Medicine Nashville, TN Dr. Thomas Broker Biochemistry Department University of Alabama at Birmingham Dr. Robert Brunham Medicine—Microbiology University of Manitoba Winnipeg, Manitoba, CANADA Dr. Francis V.Chisari The Scripps Research Institute Molecular and Experimental Medicine La Jolla, CA H.Fred Clark, D.V.M., Ph.D. The Children’s Hospital of Philadelphia Frank M.Collins, M.D. Mycobacteriology Laboratory Division of Bacterial Products Food and Drug Administration Bethesda, MD Robert Couch Microbiology and Immunology Baylor College of Medicine Houston, TX Christopher P.Crum, M.D. Brigham & Women’s Hospital Boston, MA Dr. Stephen J.Czinn Department of Pediatrics Case Western University Rainbow Babies and Children’s Hospital Cleveland, OH James B.Dale, M.D. Veterans Administration Medical Center Memphis, TN George S.Deepe, Jr., M.D. Division of Infectious Diseases University of Cincinnati Dr. Gail Demmler Pediatrics Baylor College of Medicine Houston, TX Floyd W.Denny, M.D. Chapel Hill, NC Peter Densen, M.D. Department of Internal Medicine University of Iowa Iowa City, IA Michele Estabrook, M.D. Division of Pediatric Infectious Diseases Rainbow Babies and Childrens Hospital Cleveland, OH Monica M.Farley, M.D. Departments of Medicine and Infectious Diseases Emory University School of Medicine and the VA Medical Center Atlanta, GA

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Vaccines for the 21st Century: A Tool for Decisionmaking Mark Fendrick, M.D. Department of Internal Medicine University of Michigan Hospital Ann Arbor, MI Vincent A.Fischetti, Ph.D. Rockefeller University New York, NY Stacey C.FitzSimmons, Ph.D. Cystic Fibrosis Foundation Bethesda, MD Dr. Ian H.Frazer Papillomavirus Research Unit Lions Human Immunology Laboratory University of Queensland Princess Alexandra Hospital Woolloongabba, AUSTRALIA John N.Galgiani, M.D. VA Medical Center Tucson, AZ Denise A.Galloway, Ph.D. Departments of Microbiology and Pathology University of Washington Seattle, WA Dr. Donald Ganem Microbiology and Immunology University of California School of Medicine San Francisco, CA Lutz Gissmann, Ph.D. Department of Obstetrics and Gynecology Stritch School of Medicine Loyola University Medical Center Maywood, IL Paul Glezen Microbiology and Immunology Baylor College of Medicine Houston, TX Emil Gotschlich, M.D. Laboratory for Bacterial Pathogenesis/Immunology The Rockefeller University New York, NY Dan M.Granoff, M.D. Chiron Biocine Emeryville, CA John R.Graybill, M.D. Audie L.Murphy VA Hospital Division of Infectious Diseases San Antonio, TX Harry B.Greenberg, M.D. Department of Medicine Stanford University Palo Alto, CA Thomas L.Hale, Ph.D. Department of Enteric Infections Walter Reed Army Institute of Research Washington, D.C. Dr. Scott B.Halstead Department of the Navy Naval Medical Research and Development Command National Naval Medical Center Bethesda, MD Sharon L.Hillier, Ph.D. Magee-Women’s Hospital Pittsburgh, PA

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Vaccines for the 21st Century: A Tool for Decisionmaking Harold J.Jennings, Ph.D. National Research Council of Canada Division of Biological Sciences Ottawa, Ontario CANADA Dennis L.Kasper, M.D. Channing Laboratory Harvard Medical School Boston, MA Ben Z.Katz, M.D. Northwestern University Medical School Division of Infectious Diseases The Children’s Memorial Hospital Chicago, IL Theo Kirkland, M.D. Veterans Medical Center San Diego, CA Dr. Robert Kurman Johns Hopkins Hospital Baltimore, MD Dr. Myron M.Levine University of Maryland School of Medicine Baltimore, MD Sheila A.Lukehart, Ph.D. Department of Medicine Division of Infectious Diseases Harborview Medical Center Seattle, WA Kenneth McIntosh, M.D. Division of Infectious Diseases Children’s Hospital Boston, MA Dr. Suzanne M.Michalek University of Alabama Birmingham, AL Dr. Andrew J.Morgan Department of Pathology and Microbiology School of Medical Sciences University of Bristol Bristo, UNITED KINGDOM Dr. Richard Moss School of Medicine Stanford University Stanford, CA Brian Murphy, M.D. Division of RVS, NIAID National Institutes of Health Bethesda, MD Dr. James Nataro Center for Vaccine Development The University of Maryland Baltimore, MD Kristin Nichol, M.D. Veterans Medical Center Minneapolis, MN Demosthenes Pappagianis, M.D. University of California School of Medicine Microbiology and Immunology Davis, CA Peter R.Paradiso, Ph.D. Lederle-Praxis Biologicals West Henrietta, NY

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Vaccines for the 21st Century: A Tool for Decisionmaking Robert F.Pass, M.D. Professor, Director, Pediatric Infectious Disease University of Alabama at Birmingham Gerald B.Pier, Ph.D. Harvard Medical School Boston, MA Dr. Stanley Plotkin Pasteur Merieux Connaught Co. Marnes-la-Coquette, FRANCE Alice Prince Department of Pediatrics Columbia-Presbyterian Medical Center New York, NY Justin D.Radolf, M.D. University of Southwestern Texas Department of Medicine Division of Infectious Diseases Dallas, TX Dr. Rino Rappuoli Head, Research and Development Vaccine Sclavo SA Sienna, ITALY Dr. Cliona Rooney Department of Virology St. Jude Children’s Research Hospital Memphis, TN Craig E.Rubens, M.D., Ph.D. Division of Infectious Diseases Children’s Hospital and Medical Center Seattle, WA Julius Schachter, Ph.D. Professor of Epidemiology University of California, San Francisco Chlamydia Research Laboratory San Francisco General Hospital Dr. Mark Schiffman NIH-National Cancer Institute Bethesda, MD Dr. Richard C.Schlegel Department of Pathology Georgetown University School of Medicine Washington, DC John Schrieber, M.D. Pediatric Infectious Diseases Rainbow Babies and Children’s Hospital Cleveland, OH Anne Schuchat, M.D. Meningitis and Special Pathogens Centers for Disease Control and Prevention Atlanta, GA Keerti V.Shah, Ph.D. Johns Hopkins School of Hygiene, Immunology and Infectious Disease Baltimore, MD Arnold L.Smith, M.D. University of Missouri Medical School Columbia, MO Fred Sparling, M.D. Chair, Department of Medicine University of North Carolina Chapel Hill, NC

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Vaccines for the 21st Century: A Tool for Decisionmaking Walter E.Stamm, M.D. Division of Allergy and Infectious Diseases University of Washington Medical Center Seattle, WA Stuart Starr, M.D. Allergy, Immunology, and Infectious Diseases Children’s Hospital Philadelphia, PA Dr. Allen Steere Tufts University Boston, MA David A.Stevens, M.D. Santa Clara Valley Medical Center Division of Infectious Diseases San Jose, CA Dennis Stevens, M.D., Ph.D. Veterans Affairs Medical Center Boise, ID Dr. Lode J.Swinnen Section of Hematology/Oncology Loyola University Medical Center Maywood, IL Martin A.Taubman, D.D.S., Ph.D. Department of Immunology Forsyth Dental Center Boston, MA Dr. Ram P.Tewari Department of Microbiology and Immunology Southern Illinois University Springfield, IL L.Joseph Wheat, M.D. Wishard Memorial Hospital Department of Medicine Indianapolis, IN Richard Whitley, M.D. Pediatrics, Microbiology and Medicine University of Alabama at Birmingham Dr. Gary Wormser Infectious Diseases New York Medical College Valhalla, NY Peter F.Wright, M.D. Pediatric Infectious Diseases Vanderbilt University Medical Center Nashville, TN Dr. T.C.Wu Johns Hopkins Hospital Baltimore, MD Michael Yancey, M.D. Maternal-Fetal Medicine Department of the Army Headquarters, Tripler Army Medical Center Tripler AMC, HI