The US Naval Medical Research Center (NMRC) is developing a Vaxfectin (cationic lipid-based adjuvant; Vical)-adjuvanted, tetravalent plasmid DNA vaccine. In 2008, Vical entered into an agreement with the NMRC to manufacture the vaccine, but it does not currently have a license for further development. However, the vaccine utilizes Vical’s proprietary Vaxfectin adjuvant, so commercialization would require a licensing agreement with Vical. The DNA vaccine is currently in Phase I development in the US only.
The vaccine comprises a plasmid, encoding the pre-membrane and envelope genes of all four dengue virus serotypes (DEN-1/2/3/4). The plasmid is formulated with Vical’s proprietary Vaxfectin adjuvant in a bid to increase the vaccine’s immunogenicity.
The vaccine is yet to be licensed by a commercial manufacturer, and Datamonitor Healthcare believes that this is unlikely to occur based on disappointing Phase I data and the lack of announcements regarding Phase II studies. If the DNA vaccine were to progress to Phase II development, it is likely to be targeted for use in military personnel, where its compacted three-dose schedule (days 0, 30, and 90) would be more attractive than that of Dengvaxia (tetravalent live-attenuated chimeric vaccine; Sanofi Pasteur). However, the vaccine could face fierce competition in this segment from Merck & Co’s V180 (adjuvanted, tetravalent DEN-80E subunit vaccine) and GlaxoSmithKline’s DPIV (adjuvanted, tetravalent formalin-inactivated vaccine), which also possess shortened two- or three-dose schedules.
TABLE OF CONTENTS
4 Product Profiles
4 Dengue DNA Vaccine : Dengue vaccines
LIST OF FIGURES
8 Figure 1: Dengue DNA Vaccine for dengue fever – SWOT analysis
LIST OF TABLES
5 Table 1: Dengue DNA Vaccine drug profile
6 Table 2: Dengue DNA Vaccine Phase I data in dengue fever
8 Table 3: Dengue DNA Vaccine Phase I data in dengue fever
9 Table 4: Potential dosing schedules of early-phase dengue fever vaccine candidates
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