Abstract
Dengue is the most important arbovirus worldwide and is the virus that causes dengue fever and the more severe dengue hemorrhagic fever. There are four serotypes of dengue with each possessing the ability to cause disease. Developing a preventive vaccine is the most efficient and effective way to prevent these diseases, and because immunity to one serotype does not protect against the other serotypes, a vaccine must provide tetravalent protection. We used DNA immunization as a platform to develop a tetravalent vaccine. In this chapter, we describe the laboratory, regulatory, and clinical methodology for evaluating a candidate tetravalent vaccine in a Phase 1 clinical trial.
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Acknowledgements
We thank Dr. Peifang Sun, Ms. Monika Simmons, and Mr. Dan Ewing for their input on the laboratory test procedures. The views expressed in this chapter are those of the author and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, nor the US Government. We are employees of the US Government. This work was prepared as part of my official duties. Title 17 U.S.C. article 105 provides that “Copyright protection under this title is not available for any work of the United States Government.” Title 17 U.S.C. article 101 defines a US Government work as a work prepared by a military service member or employee of the US Government as part of that person’s official duties. For the clinical trial described in this chapter, the NMRC Institutional Review Board, along with the US Army Human Subjects Research Review Board, reviewed and approved the study protocol in compliance with all applicable federal regulations governing the protection of human subjects.
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Porter, K.R., Teneza-Mora, N., Raviprakash, K. (2014). Tetravalent DNA Vaccine Product as a Vaccine Candidate Against Dengue. In: Rinaldi, M., Fioretti, D., Iurescia, S. (eds) DNA Vaccines. Methods in Molecular Biology, vol 1143. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-0410-5_17
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DOI: https://doi.org/10.1007/978-1-4939-0410-5_17
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