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Four serotypes of monovalent live attenuated dengue virus vaccine candidates were tested for reactogenicity and immunogenicity in 49 flavivirus non-immune adult human volunteers. The four monovalent candidates were then combined into a tetravalent formulation and given to another 10 volunteers. Neutralizing antibody seroconversion rates after a single-dose monovalent vaccination ranged from 53% to 100%. Solicited reactogenicity was scored by each volunteer. A composite index, the Reactogenicity Index, was derived by these self-reported scores. Reactogenicity differed among the four serotype candidates with serotype-1 associated with the most vaccine related side effects. A second dose of monovalent vaccines at either 30 days or 90 days was much less reactogenic but did not significantly increase seroconversion rates. Seroconversion rates in the 10 volunteers who received a single dose of tetravalent vaccine ranged from 30% to 70% among the four serotypes. Similar to the monovalent vaccines, a second dose of the tetravalent vaccine at one month was less reactogenic and did not increase seroconversion. A third dose of the tetravalent vaccine at four months resulted in three of four volunteers with trivalent or tetravalent high-titer neutralizing antibody responses.
Acknowledgments: We thank all the volunteers, and our clinical coordinators (Jennifer Sun, Denise McKinney, Sheila Taylor, and Kathy Palmer), all of whose dedication made the successful completion of these studies possible.
Financial support: The studies were supported by the United States Army Medical Research and Materiel Command.
Disclaimer: The views expressed herein are those of the authors and do not necessarily represent those of the Department of the Army or Department of Defense.
Authors’ addresses: Wellington Sun, Niranjan Kanesa-thasan, J. Robert Putnak, and Huo-Shu Houng, Division of Communicable Diseases and Immunology, Department of Virus Diseases, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910, Telephone: 301-319-9493, Fax: 301-319-9661, E-mail: wellington.sun{at}na.amedd.army.mil. Robert Edelman, Department of Medicine and the Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD 21201. Kenneth H. Eckels, Department of Biologics Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910. Alan D. King, Cyto Pulse Sciences, Inc., PO Box 609, Columbia, MD 21045. Douglas Tang, Division of Biometrics, Walter Reed Army Institute of Research, Silver Spring, MD 20910. John M. Scherer, Theatre Army Medical Laboratory, United States Army Medical Research and Materiels Command, Fort Detrick, Frederick, MD 21702-5011. Charles H. Hoke, Jr., Office of the Surgeon General, SARTF, 5111 Leesburg Pike, Sky 5, Suite 401, Falls Church, VA 22041-3258. Bruce L. Innis, GlaxoSmithKline, 1250 South Collegeville Road, Mail Code UP4330, Collegeville, PA 19426-0989.
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