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U.S. Navy and U.S. Army to Develop Dengue DNA Vaccine Formulated With Vical's Vaxfectin(R) Adjuvant
Date:11/6/2008

delivered with the Biojector(R) 2000 needle-free injection system. Preliminary results indicated that the vaccine was safe and well-tolerated at both the 1 mg low dose and 5 mg high dose tested, but even at the high dose induced only low levels of neutralizing antibody titers in less than half of the animals. Under a Collaborative Research and Development Agreement (CRADA) with Vical, the NMRC developed a tetravalent dengue vaccine containing prM and E genes for all four serotypes of dengue, and formulated with the Vaxfectin(R) adjuvant. Nonhuman primate immunogenicity and challenge data with the tetravalent DNA vaccine, formulated with or without the Vaxfectin(R) adjuvant and delivered by needle-free injection using the Biojector(R) 2000, were promising.

Four of four (100%) rhesus macaques receiving the Vaxfectin(R)-formulated vaccine developed neutralizing antibodies to all four serotypes of dengue one month after the second injection (Day 56), and were highly protected against challenge, exhibiting very limited viremia (group mean 0.75 days). Only one of four (25%) macaques receiving the unformulated vaccine developed neutralizing antibodies to all four serotypes of dengue one month after the second injection (Day 56), and were partially protected against challenge, exhibiting limited viremia (group mean 2.00 days). The unvaccinated control macaques did not develop any neutralizing antibodies, and were unprotected against challenge, exhibiting typical viremia (group mean 3.33 days). The next step in this program will be to advance this vaccine to Phase 1 human testing.

About Dengue

Dengue virus infects up to 100 million people each year. Its impact is magnified by the lack of effective antiviral drugs and vaccines. As many as half a million people develop severe dengue disease each year, causing tens of thousands of deaths, particularly where healthcare is limited.

Dengue fever can be caused by any one of four serotypes of dengue virus
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SOURCE Vical Incorporated
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