DPIV is a tetravalent, AS03B-adjuvanted, purified formalin-inactivated dengue virus vaccine being developed by GlaxoSmithKline in collaboration with the US Walter Reed Army Institute of Research and the Oswaldo Cruz Foundation in Brazil. The four dengue virus serotypes (DEN-1/2/3/4) are grown in Vero cells before being concentrated, purified, and formalin-inactivated.
DPIV is currently in Phase I/II development in the US and Puerto Rico only, but will likely be assessed in Phase II proof-of-concept studies in the same dengue-endemic markets as Dengvaxia (tetravalent live-attenuated chimeric vaccine; Sanofi Pasteur) and TAK-003 (tetravalent live-attenuated chimeric vaccine; Takeda).
Having shelved the development of its own live-attenuated vaccine (LAV), GlaxoSmithKline has decided to pursue the approval of an inactivated vaccine because of the reduced likelihood of serotype interference, and the potential for a more compact dosing schedule. As an anticipated late entrant into the dengue vaccine market, DPIV’s commercial success will be dependent on its ability to provide at least non-inferior protection to the tetravalent live-attenuated chimeric vaccines Dengvaxia and TAK-003 with a shorter two-dose schedule, either as a standalone agent, or as part of a heterologous prime-boost strategy with an LAV. DPIV’s more convenient dosing schedule could also make it an attractive option for travelers and the military, although the vaccine is expected to face competition in these segments from Merck & Co’s V180 (adjuvanted, tetravalent DEN-80E subunit vaccine), which is also being assessed in a heterologous prime-boost strategy with TetraVax-DV (tetravalent live-attenuated chimeric vaccine; Biological E/Panacea Biotec/Butantan Institute/Merck & Co/Vabiotech).
TABLE OF CONTENTS
4 Product Profiles
4 DPIV : Dengue vaccines
LIST OF FIGURES
10 Figure 1: DPIV for dengue fever – SWOT analysis
LIST OF TABLES
5 Table 1: DPIV drug profile
7 Table 2: DPIV completed Phase I studies in dengue fever
10 Table 3: DPIV ongoing studies in dengue fever
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