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. BIOGRAPHICAL SKETCH OF DR. ANTHONY S. FAUCI December 24, 1940. Brooklyn, New York Education: College of Holy Cross, 1962 A.B.; Cornell University Medical College, 1966 M.D. Professional History: 1966-1967, Intern, Department of Medicine, New York Hospital-Cornell Medical 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 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 Member, Scientific Advisory Board, Medical Biology Institute, La Jolla, Research Programs on the Acquired Immunodeficiency Syndrome of the Ministry of 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: 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, 44th 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. 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 MicroGeneSys? 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 |