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Am. J. Trop. Med. Hyg., 69(6 suppl), 2003, pp. 17-23
Copyright © 2003 by The American Society of Tropical Medicine and Hygiene

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PHASE 1 STUDIES OF WALTER REED ARMY INSTITUTE OF RESEARCH CANDIDATE ATTENUATED DENGUE VACCINES: SELECTION OF SAFE AND IMMUNOGENIC MONOVALENT VACCINES

N. KANESA-THASAN, R. EDELMAN, C. O. TACKET, S. S. WASSERMAN, D.W. VAUGHN, T. S. COSTER, G. J. KIM-AHN, D. R. DUBOIS, J. R. PUTNAK, A. KING, P. L. SUMMERS, B. L. INNIS, K. H. ECKELS, AND C. H. HOKE, JR.
Walter Reed Army Institute of Research, Washington, District of Columbia; Department of Medicine and the Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland; United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Frederick, Maryland

We describe the results of initial safety testing of 10 live-attenuated dengue virus (DENV) vaccine candidates modified by serial passage in primary dog kidney (PDK) cells at the Walter Reed Army Institute of Research. The Phase 1 studies, conducted in 65 volunteers, were designed to select an attenuated vaccine candidate for each DENV serotype. No recipient of the DENV candidate vaccines sustained serious injury or required treatment. Three vaccine candidates were associated with transient idiosyncratic reactions in one volunteer each, resulting in their withdrawal from further clinical development. Increasing PDK cell passage of DENV-1, DENV-2, and DENV-3 candidate vaccines increased attenuation for volunteers, yet also decreased infectivity and immunogenicity. This effect was less clear for DENV-4 candidate vaccines following 15 and 20 PDK cell passages. Only one passage level each of the tested DENV-2, -3, and -4 vaccine candidates was judged acceptably reactogenic and suitable for expanded clinical study. Subsequent studies with more recipients will further establish safety and immunogenicity of the four selected vaccine candidates: DENV-1 45AZ5 PDK 20, DENV-2 S16803 PDK 50, DENV-3 CH53489 PDK 20, and DENV-4 341750 PDK 20.

Authors’ addresses: N. Kanesa-thasan, T. S. Coster, G. J. Kim-Ahn, and P. L. Summers, Medical Division, United States Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, Frederick, MD 21702, Telephone: 301-619-4595, Fax: 301-619-2511, E-mail: niranjan.kanesa-thasan{at}det.amedd.army.mil. R. Edelman, C. O. Tacket, and S. S. Wasserman, Department of Medicine and the Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD 21201. D. W. Vaughn and J. R. Putnak, Division of Communicable Diseases and Immunology, Department of Virus Diseases, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910. D. R. Dubois, Vaccine Research Center, Building 40, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, Bethesda, MD 20892. A. King, Cyto Pulse Sciences, Inc., PO Box 609, Columbia, MD 21045. B. L. Innis, GlaxoSmith-Kline, 1250 South Collegeville Road, Mail Code UP4330, Collegeville, PA 19426-0989. K. H. Eckels, Department of Biologics Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910. C. H. Hoke, Jr., Office of the Surgeon General, SARTF, 5111 Leesburg Pike, Sky 5, Suite 401, Falls Church, VA 22041-3258.




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ERRATA
Am J Trop Med Hyg, March 1, 2004; 70(3): 336 - 337.
[Full Text] [PDF]


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Copyright © 2003 by the American Society of Tropical Medicine and Hygiene.