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that a candidate vaccine for large-scale testing in uninfected volunteers will

be identified within the next few years.

From the unexplored mysteries of the immune system to the threat of new

and re-emerging microbes, NIAID faces important challenges in the decade of

the 1990s.

Our commitment to basic research in immunology and microbiology

has in the past positioned us well to meet such challenges.

Our renewed

commitment to this approach will surely allow us to turn these challenges into

opportunities to alleviate and hopefully prevent suffering and death caused by

infectious diseases and disorders of the immune system.

Mr. Chairman, the FY 1992 budget request for this Institute is

$976,711,000.

I will be pleased to answer any questions you may have.

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1966-1967, Intern, Department of Medicine, New York Hospital-Cornell Medical
Center. 1967-1968, Assistant Resident, Department of Medicine, The New York
Hospital-Cornell Medical Center. 1968-1970, Clinical Associate, Laboratory of
clinical Investigation, National Institute of Allergy and Infectious Diseases
(NIAID), National Institutes of Health (NIH), Bethesda, Maryland. 1970-1971,
Senior Staff Fellow, Laboratory of Clinical Investigation, NIAID, NIH,
Bethesda, Maryland. 1971-1972, Chief Resident, Department of Medicine, New
York Hospital-Cornell Medical Center; Instructor in Medicine, Cornell Medical
College. 1972-1974, Senior Investigator, Laboratory of clinical
Investigation, NIAID, NIH, Bethesda, Maryland. 1972-present, Consultant in
Infectious Diseases, The National Naval Medical Center, Bethesda, Maryland.
1974-1980, Head, Clinical Physiology Section, Laboratory of Clinical
Investigation, NIAID, NIH, Bethesda, Maryland. 1977-1984, Deputy Clinical
Director, NIAID, NIH, Bethesda, Maryland. 1980-present, Chief, Laboratory of
Immunoregulation, NIAID, NIH, Bethesda, Maryland. 1984-1988, Clinical
Professor, Department of Medicine, Division of Rheumatology, Immunology, and
Allergy, Georgetown University School of Medicine, Washington, D.C. 1985-
1988, Clinical Professor, George Washington University School of Medicine and
Health Sciences, Washington, D.C. 1984-present, Director, NIAID, NIH,
Bethesda, Maryland. 1988-present, Director, Office of AIDS Research, NIH, and
Associate Director of NIH for AIDS Research, Bethesda, Maryland.

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Board Certification and Military Service:

American Board of Internal Medicine-June 21, 1972. American Board of Allergy and Immunology-March 1, 1974. American Board of Infectious Diseases-October 15, 1974. U.S. Public Health Service, July 1968-June 1970; July 1972- Present.

Professional Organizations :

American Federation for clinical Research, American Association for the
Advancement of Science, American Association of Immunologists, American

Medical Association, Fellow of the American Academy of Allergy, Infectious Diseases Society of America, American Society for Clinical Investigation, Fellow of The American College of Physicians, Association of American Physicians, Collegium Internationale Allergologicum, Charter Member of the Clinical Immunology Society. The Institute of Medicine of the National Academy of Sciences (USA).

Offices Held:

Councillor, Eastern Section, American Federation for Clinical Research (AFCR), 1977.

National Councillor, AFCR, 1978-1979. President, AFCR, 1980-1981. Recorder, Association of American Physicians, 1988-present.

Advisory Boards and Committees :

Chairman, Allergy and Immunology Committee, MKSAP V, American College of
Physicians. Advisory Panel, The American Board of Medical Laboratory
Immunology. Member, Committee on Clinical Immunology and Immunopathology,
American Association of Immunologists, 1980-1985. Representative of American
Association of Immunologists to the Examinations Committee of the American
Board of Allergy and Immunology, 1981-present. Postgraduate Education
Committee, American Academy of Allergy, 1979-1982. Member, NIAID Study Group
on Immunology, 1980. Member, Section of Physiology in Clinical Science of the
American Physiological Society, 1980-1984. Member, Subcommittee on the
Classification of vasculitis, American Rheumatism Association 1980-present.
Ad Hoc Committee, The National Foundation for Infectious Diseases, 1980-
present. Subcommittee on clinical Sciences, Publications Committee, American
Physiological Society, 1980-1984. American Association of Immunologists,
1982-1985. Member, NIAID Working Group for AIDS, 1982-present. Member,
American Federation for Clinical Research President's Public Policy Advisory
Committee, 1983-present. Board of Directors, American Board of Allergy and
Immunology, 1984-1987. Participant in the USA · People's Republic of China
Immunology Cooperative Agreement, August 10-22, 1983, Beijing and Shanghai,
PRC. Member, Scientific Advisory Board, Medical Biology Institute, La Jolla,
CA, 1983-1984. Participant in the USA-Japan Eye Immunology Advisory
Conference, November 27 to December 1, 1983, Honolulu, HI. Member, External
Advisory Committee, Multipurpose Arthritis Center, Duke University Medical
Center, 1984-present. Member, Honorary Advisory Board, Italian-American
Medical Association, 1984 - present. Member, Peripatetic Club, 1984-present.
Ex officio Member, National Diabetes Advisory Board, 1984-present. Ex Officio
Member, National Digestive Diseases Advisory Board, 1984-present. Chairman,
Search Committee for Director, National Institute of Child Health and Human
Development, 1985. Member, Department of Health and Human Services Task Force
on Alzheimer's Diseases. The Albert Lasker Medical Research Award Jury, 1985.
present. Deputy Ethics Counselor, Department of Health and Human Services,
1985.present. Member, Department of Health and Humans Services Committee to
Coordinate Environmental and Related Programs, 1985-present. Member,
Scientific Organizing Committee, Joint Meeting of the Italian Society of
Immunology and Immunopathology-National Institutes of Health on "Human
Lymphocyte Activation," Florence, Italy, September 5-7, 1985. Member, United
States Delegation to the United States-Japan Cooperative Medical Science
Committee, 1985-present. Member, U.S. Public Health Service AIDS Executive
Task Force, 1985-present. Chairman, NIH AIDS Executive Task Force, 1985-
present. Coordinator, NIH AIDS Research, 1985-present. Member, Scientific
Seminar Subcommittee, National Institutes of Health Centennial Program, 1985-
1987. Member, Advisory Board, Clinical Immunology Newsletter, 1986-1988.
Member, Scientific Organizing Committee, International Conference on
Lymphocyte Activation and Immune Regulation, Newport Beach, CA, February 28 -
March 2, 1986. Member, Planning Committee, Clinical Immunology Society, 1986.
Member, International Adyisory Committee, International Conference on AIDS,
Paris, France, June 23-25, 1986. Member, Advisory Group, Institut
Scientifique Roussel-Uclaf, 1987-1989. Ex Officio Member, National Kidney and
Urologic Diseases Advisory Board, 1987-present. Member, International
Programme Committee, 8th International Congress of Immunology, Budapest,
Hungary, 1987. Member, International Advisory Committee, IVth International
Conference on AIDS, Stockholm, Sweden, June 12-16, 1988. Member, NIH Resource
Allocation Group. 1987-1989. Member, Committee for the Coordination of

Research Programs on the Acquired Immunodeficiency Syndrome of the Ministry of
Health of Italy, 1988-present. Institute of Medicine Roundtable for the
Development of Drugs and Vaccines Against AIDS, January 17, 1989, through
December 31, 1991. Member, Selection Committee for the National Public
Service Awards, 1990.

Editorial Boards:

Dr. Fauci has been or is on the Editorial Board of 27 scientific journals in the field of immunology, allergy and infectious diseases. These include: The Journal of Clinical Investigation, The Journal of Immunology, Journal of Infectious Diseases, Journal of Clinical Immunology. Dr. Fauci is also the Editor of one of the major textbooks of medicine in the world, "Harrison's Principles of Internal Medicine."

Awards and Honors:

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Alpha Omega Alpha. Kileen Prize for Excellence in Chemistry (College of the Holy Cross). John Metcalfe Polk Prize for General Efficiency (Cornell University Medical College). Alfred Mortitz Michaelis Prize for Efficiency in General Medicine (Cornell University Medical College). U.S. Public Health Service Meritorious Service Award, 1979. Arthur S. Flemming Award, 1979 · Given to the 10 outstanding employees in the U.S. Federal Government. Squibb Award of the Infectious Diseases Society of America, 1983. U.S. Public Health Service Distinguished Service Medal, 1984. Food and Drug Administration Commissioner's Special Citation, 1984. 1985 Citation Classics (Current Contents) for article A.S. Fauci, D.C. Dale, and J.E. Balow: Glucocorticosteroid therapy: mechanisms of action and clinical considerations. Ann. Intern. Med. 84: 304-315, 1976. Who's Who in America, 44 th Edition. Who's Who in Science and Technology, 2nd Edition. 1985 Stanford University Center Survey of the American Rheumatism Association membership ranked the work of Dr. Anthony S. Fauci on the treatment of polyarteritis nodosa and Wegener's granulomatosis as one of the most important advances in patient management in rheumatology over the past 20 years. The Clemens von Pirquet Award of Georgetown University Medical Center, 1986. Doctor of Science, Honoris Causa, College of the Holy Cross, Worcester, MA May 29, 1987. The Kober Lecture Award of the Association of American Physicians, 1988. Public Health Leader of the Year Award of the Commissioned Officers Association of the U.S. Public Health Service, 1988. The National Institutes of Health Clinical Center Annual Distinguished clinical Educator Award, 1988. 1988 Citation Classics (Current Contents) for article A. S. Fauci, B. F. Haynes, P. Katz: The spectrum of vasculitis. Ann. Intern Med. 89: 660-676, 1978. The Leadership Award of the Columbus Citizens Foundation, Inc., for "Inspired Leadership and Outstanding Achievement in the field of Medical Research," New York, NY October 8, 1988. American Association for the Advancement of Science Westinghouse Award for Public Understanding of Science and Technology, 1988. The National Hemophilia Foundation Special Award for Research in AIDS, 1989. The Lee P. Brown National Public Service Award of 1989 presented by the National Academy of Public Administration and the National Society for Public Administration, The Duke University Award for Rheumatologic and Immunologic Research, 1989. The William Beaumont Award of the American Medical Association, 1989. The academic Excellence Award from Children's Hospital National Medical Center, Washington, DC, 1989. The Surgeon General's Exemplary Service Medal, 1989. The Surgeon General's Medallion, 1989. The 1989 Achievement Award of the American Association of Physicians for Human Rights. The 1989 National Medical Research Award of the National Health Council. The Flame of Hope Award of the Terri Gotthelf Lupus Research Institute, November 2, 1989. The 1989 Maxwell Finland Award in Infectious Disease presented by the National Foundation for Infectious Diseases. The 1989 Helen Hayes Award for Medical Research. The Excellence in Public Service Award of the Committee for the Support of Public Service, May 9, 1990. The 1990 Lifetime Science Award of the Institute for Advanced Studies in Immunology and Aging, Washington, DC. Doctor of Science, Honoris Causa, Mount Sinai School of Medicine, New York, NY, May 18, 1990. Doctor of Science, Honoris Causa, Neumann College, Aston, PA, May 19, 1990. Doctor of Science, Honoris Causa, Georgetown University School of Medicine, Washington, DC, May 26, 1990. Doctor of Science, Honoris Causa, Hahnemann University

Graduate School and School of Medicine, Philadelphia, PA, June 1, 1990. 1990 Science Citation Index ranked Dr. Fauci as the eighth most.cited scientist among 1.3 million scientists publishing in the time period 1981-1988. 1990 Humanitarian Award of the Human Rights Campaign Fund Federal Club of Houston. The First International Chiron Prize for Biomedical Research awarded by the Scuola Superiore di Oncologia e Scienze, B Biomediche (Genoa) and the Scuola Internationale di Oncologia e Medicine Sperimentale (Rome), 1990. Doctor of Medicine and Surgery, Honoris Causa, Universita di Roma, "La Sapienza," Rome, Italy, 1990. The Fifth Annual Gene Frey Memorial Award for Medicine, The Whitman-Walker Clinic, Washington, DC, November 17, 1990. The 1990 Presidential Award of the New York Academy of Sciences. Visiting Professor of Medicine at a large number of major medical schools throughout the country.

Publications:

Dr. Fauci has authored over 700 scientific publications in the field of basic and clinical immunology and infectious diseases.

VACCINES

Senator HARKIN. Thank you very much, Dr. Fauci.

Let me just ask you a couple of questions about the vaccines. One has to do with the licensed vaccine to protect infants against meningitis.

Dr. FAUCI. Right.

Senator HARKIN. This is a long-term interest area of mine. Is this the same kind of meningitis that causes hearing loss?

Dr. Fauci. Yes; both hearing loss and mental retardation may result from Haemophilus influenzae type b.

Senator HARKIN. And is this vaccine now available?
Dr. Fauci. Yes.

Senator HARKIN. What is the earliest age that a child can take that vaccine, and who should take it?

Dr. Fauci. Well, this is the first time since the 1960's that we have a new vaccine against an important childhood disease. The reason this is so important is that children, by the nature of the development of their immune system, cannot seem to make immune responses against what we call polysaccharide components of bacteria until they are 1, 2, or 3 years old and sometimes even older. However, this particular type of meningitis usually affects children who are much younger, within months of birth.

The advances here and this was a very important contribution of one of the intramural scientists in the National Institute of Child Health and Human Development-was to develop a combination of a protein conjugate with the polysaccharide to allow the infant's immune system to recognize and respond to this. So, now we have a vaccine available that may be used when the infant is most vulnerable. So, this is a very, very important advance. Prior to this, we could not vaccinate children then because their immune systems would not recognize the particular bacteria.

Senator HARKIN. So, you can vaccinate them at
Dr. FAUCI. A few months.
Senator HARKIN (continuing). A few months of age.
Dr. Fauci. Yes.

Senator HARKIN. And does this protect them for—is it like a smallpox vaccination? I don't know what the right phrase is, but they do not have to be revaccinated later on or anything like that?

Dr. Fauci. No; actually the important thing is that children are very vulnerable to this. When they become adults, they are much, much less vulnerable to this. So, that period is the critical period.

Senator HARKIN. I understand.

We have provided funding-staying on vaccines here and encouragement for development of a children's vaccine. I know Senator Bumpers has been very active in that area. This would be one vaccine which would cover seven or eight of the more common childhood vaccines all in one dose.

How optimistic are you that such a vaccine can be developed in the relatively near future?

Dr. Fauci. Well, we are optimistic about this, Senator, because we feel that we have already in place the basic research knowledge that can at least get a very good start on this. What we need to do now is to apply some of that technology to the development of this, as well as to continue our effort in basic research in that area. And I could just very briefly give you some of the objectives as you mentioned.

The first thing is to have a vaccine which is stable at ambient temperature, that is administered orally, and that can produce lifelong immunity when administered as a single dose in childhood.

What have we been doing over the past year with the money that you have given us to try and implement the basic science to get such a vaccine?

Well, first what we have done is that we have established a vaccine production facility. We have accelerated our research on mucosal immunity, and we have evaluated vaccine prophylaxis against infectious diseases in children that we have not had as much effort on. Right now we are studying the concept of maternal immunization, both in an animal model and in the human system. So, already this year we have had activity heading toward the goal of a children's vaccine and I think it is a feasible goal within this decade.

Senator HARKIN. I was contacted recently about the AIDS vaccine which has been developed by MicroGeneSys. Are you familiar with that?

Dr. Fauci. I am very familiar with it, yes, sir.

Senator HARKIN. I understand that the drug is ready to move into phase II clinical trials to determine whether or not the drug is effective.

What is the status of the clinical trials for the AIDS vaccine developed by MicroGene Sys?

Dr. Fauci. Yes, Mr. Chairman. The MicroGeneSys vaccine is a recombinant vaccine of the GP-160 protein of the envelope of HIV.

In 1987, we initiated a phase I Clinical trial in the intramural program using accelerated doses of the GP-160. We have just recently initiated the GP-160 in individuals who are already infected with HIV using it namely as an immunoadjuvant.

In addition, in our vaccine evaluation units extramurally, we are testing the GP-160, and it has been used as a boost in association with a Bristol Myers product, which is a high vaccinia initial dose and then boosted secondarily with the MicroGeneSys vaccine.

With regard to your specific question, we have called together a group of experts on an ad hoc basis to advise us on whether we

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