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.)?
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).
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
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
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
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
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
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