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DNA Rpt Covers Final The Scientific Future of DNA for Immunization 1 Copyright © 1997 American Society for Microbiology American Academy of Microbiology 1325 Massachusetts Avenue, NW Washington, DC 20005-4171 E-mail: [email protected] Fax: (202) 942-9380 2 The Scientific Future of DNA for Immunization Prepared by: Harriet L. Robinson, Ph.D. Harold S. Ginsberg, M.D. Heather L. Davis, Ph.D. Stephen A. Johnston, Ph.D. Margaret A. Liu, M.D. A report from The American Academy of Microbiology Available on-line at http://www.asmusa.org/acasrc/aca1.htm 3 C O L L O Q U I U M S T E E R I N G C O M M I T T E E Harold S. Ginsberg, M.D. (Co-Chair) National Institutes of Health Harriet L. Robinson, Ph.D. (Co-Chair) University of Massachusetts Medical School Heather L. Davis, Ph.D. Loeb Medical Research Institute Stephen A. Johnston, Ph.D. University of Texas, Southwestern Medical Center Margaret A. Liu, M.D. Chiron Corporation B O A R D O F G O V E R N O R S American Academy of Microbiology Rita R. Colwell, Ph.D., Sc.D. (Chair) University of Maryland Biotechnology Institute Joseph M. Campos, Ph.D. Children’s National Medical Center R. John Collier, Ph.D. Harvard Medical School Julian E. Davies, Ph.D. University of British Columbia Harold S. Ginsberg, M.D. National Institutes of Health Martha M. Howe, Ph.D. University of Tennessee, Memphis Mary E. Lidstrom, Ph.D. University of Washington Eugene W. Nester, Ph.D. University of Washington Mary Jane Osborn, Ph.D. University of Connecticut Health Center Moselio Schaechter, Ph.D. San Diego State University Melvin I. Simon, Ph.D. California Institute of Technology 4 C O L L O Q U I U M P A R T I C I P A N T S Abul K. Abbas, MBBS Margaret A. Liu, M.D. Harvard Medical School Chiron Corporation Boston, Massachusetts Emeryville, California M. Teresa Aguado, Ph.D. Pierre Meulien, Ph.D. World Health Organization Pasteur Mérieux Serums and Vaccines Geneva, Switzerland March L’Etoile, France Heather L. Davis, Ph.D. Bernard Moss, M.D., Ph.D. Loeb Medical Research Institute National Institutes of Health Ottawa, Canada Bethesda, Maryland Hildegund C.J. Ertl, M.D. Carol A. Nacy, Ph.D. Wistar Institute, University of Pennsylvania Rockville, Maryland Philadelphia, Pennsylvania Terence A. Partridge, Ph.D. Harold S. Ginsberg, M.D. Royal Postgraduate Medical School National Institutes of Health London, England Rockville, Maryland David S. Pisetsky, M.D., Ph.D. Joel R. Haynes, Ph.D. Duke University Medical Center Agracetus Inc. Durham, North Carolina Middleton, Wisconsin Ian Ramshaw, Ph.D. Maurice R. Hilleman, Ph.D. Australian National University Merck Institute for Therapeutic Research Canberra, Australia West Point, Pennsylvania Harriet L. Robinson, Ph.D. Vanessa Hirsch, D.Sc. University of Massachusetts Medical School National Institutes of Health Worcester, Massachusetts Rockville, Maryland Michael Sheppard, Ph.D. Stephen L. Hoffman, M.D., D.T.M.H. Pfizer Central Research Naval Medical Research Institute Lincoln, Nebraska Rockville, Maryland Frederick R. Vogel, Ph.D. Stephen A. Johnston, Ph.D. National Institutes of Health University of Texas, Southwestern Medical Center Bethesda, Maryland Dallas, Texas Britta Wahren, Ph.D. Dennis Klinman, M.D., Ph.D. National Bacteriology Laboratory Food and Drug Administration Stockholm, Sweden Rockville, Maryland Robert G. Webster, Ph.D. Myron M. Levine, M.D., D.T.M.H. St. Jude’s Children’s Hospital University of Maryland School of Medicine Memphis, Tennessee Baltimore, Maryland David B. Weiner, Ph.D. University of Pennsylvania Philadelphia, Pennsylvania 5 6 EXECUTIVE SUMMARY novel approach to the development of needed vaccines A uses DNA for immunization. DNA represents the genetic blueprint for life. When DNA is used for immunization, the DNA in plasmid form provides the code for the vaccinating protein. The actual production of the immunizing protein takes place in the DNA-inoculated host, initiating both humoral and cellular immunity. DNA vaccines are administered in saline using hypodermic needles or by propelling DNA-coated gold beads into skin using gene guns. Recent results obtained in animal models indicate that this new technology may revolutionize the vaccination of humans. Protective immunity has been achieved for such major killers as diarrhea-causing viruses, tuberculosis-inducing bacteria, and malaria-inducing parasites. These new DNA vaccines also hold promise for being safer, less expensive, and easier to produce and administer than conventional vaccines. This report is based on a colloquium of experts convened to consider this new and extremely promising technology. 7 INTRODUCTION Historical Importance of Vaccination infectious agents remain major killers and and the Need for New, Improved debilitators (see Figure 1), despite worldwide Vaccines improvements in sanitation and vaccination. Emerging infections, the reemergence of historical scourges, and microorganisms as yet he widespread use of vaccines has uncontrolled continue to pose major risks to resulted in the global eradication of world health. smallpox,1 the near elimination of Tpoliomyelitis and measles from the United Emerging diseases. Increased population States,2 and dramatic reductions in cases of density, the soaring frequency of travel, and the diphtheria, tetanus, whooping cough, mumps, juxtaposition of species in changing natural and rubella (German measles) (see Table 1).2,3 environments promote the emergence and No other medical procedure has had such dissemination of infectious agents (see Figure profound and long-lasting effects on world 2).4,5,6 HIV-1, the virus that induces AIDS, health. No other medical procedure has unrecognized in human populations before resulted in the actual eradication of disease or 1984, has become the eighth leading cause of rivaled the cost effectiveness of vaccines. Each death in the United States and now infects an development of a vaccine has proved a triumph estimated 24,000,000 adults worldwide. of humankind against disease. Nonetheless, Horrifying viruses that cause hemorrhagic fevers, such as the Ebola virus of central Africa and the Hanta viruses of mice, have scrambled Table 1. Comparison of Maximum and Current for brief, but unsuccessful, toeholds in human 1 Morbidity for Vaccine-Preventable Diseases populations. Although multi-drug therapies are Disease Maximum Year 1992 Percentage providing new hope for stemming the inexo- Cases Change rable progression of HIV-1 infected humans to Diptheria 206,939 1921 4 -99.99 AIDS, relatively few nations can provide these Measles 894,134 1941 2,237 -99.75 expensive and regimented treatments. True Mumps2 152,209 1968 2,572 -98.31 control of AIDS awaits an effective vaccine. Pertussis 265,269 1934 4,083 -98.46 The ultimate promise for containment of such Polio (paralytic) 21,269 1952 43 -99.98 emergent agents as Ebola and Hanta also lies in Rubella4 57,686 1969 160 -99.72 vaccine development. CRS5 20,000 1964-65 11 -99.95 Reemerging diseases. Microorganisms not Tetanus6 1,560 1923 45 -97.12 eliminated by drugs or vaccines pose continuing Haemophilus threats of reemergent pandemics.4 Dreaded, influenzae type b 20,0007 1984 1,412 -92.94 drug resistant forms of tuberculosis have Hepatitis B 26,611 1985 16,126 -39.40 emerged not only in humans but in cattle and 1Adapted from (11). deer.7 Tuberculosis is responsible for more 2First reportable in 1968. deaths in adults than any other single infectious 3Subject to change due to retrospective case evaluation of late reporting. agent. The combination of increasing numbers 4First reportable in 1966. of immunocompromised individuals with HIV 5Congenital rubella syndrome estimated for the 1964–65 pandemic. infections and the emergence and spread of 6Cases first reportable in 1947. Maximum based on number of deaths. multi-drug resistant tubercule bacilli has led to 7First reportable in 1991. Estimate based on five U.S. population-based studies, 1976–84. a dramatic worsening of the impact of this disease. Malaria is a major killer of both 8 Figure 1. Major Causes of Death in the World A. All ages, 1995 estimates B. Children under 5 years of age, 1992 estimates hook worm dengue Ieishmaniasis meningitis pertussis (whooping cough) tuberculosis (children) tetanus (neonatal) acute respiratory infections (viral) AIDS pertussis measles neonatal tetanus hepatitis B virus viral diarrhea malaria malaria tuberculosis measles diarrhea bacterial diarrhea Diseases in order of increasing importance of increasing Diseases in order acute importance of increasing Diseases in order respiratory acute respiratory infections infections (bacteria) 012 345 012 345 Millions of deaths per year Millions of deaths per year Figure 2. New Infectious Diseases in Humans and Animals Since 1976. Countries where cases first appeared or were identified 1988 Salmonella enteritidis PT4 United Kingdom 1986 Bovine spongiform 1982 encephalopathy* E.coli United Kingdom 0157:H7 1989 1980 United States 1980 Hepatitus C Hepatitus D Human T-cell 1981 United States (Delta) 1976 lymphotropic virus 1 AIDS Italy Cryptosporidiosis Japan United States United States 1977 1976 1991 Hantaan virus Legionnaires‘ Disease Venezuelan Republic of Korea haemorrhagic fever United States 1992 Venezuela Vibrio cholerae 0139 India 1994 1976 Brazilian Ebola haemorrhagic fever haemorrhagic fever 1994 Brazil Zaire Human and equine morbilivirus Australia *Animal cases only. World Health Organization. 1993. Ten Years of Progress 1984–1993. The Programme for Vaccine Development. 9 children and adults. Emergence of resistance of drug resistant tuberculosis threatens to become the parasites to antimalarial drugs and of the the norm, and enterobacteria that cause critical mosquito vectors to insecticides, the deteriora- diarrheal diseases often prove resistant to tion of the health care systems of countries in antibiotic treatment.10 These increases in turmoil, and the refugee crisis resulting in the resistance stem from excessive use of antibiotics movement of non-immune individuals to malari- in patient populations, as well as the use of ous areas have resulted in malaria reemerging agents with clinical applications in agriculture where it was once under control and worsening and aquaculture.
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