TAK-003
TAK-003 or DENVax is a recombinant chimeric vaccine with DENV1, DENV3, and DENV4 components on a dengue virus type 2 (DENV2) backbone originally developed at Mahidol University in Bangkok and now funded by Inviragen (DENVax) and Takeda (TAK-003). Phase I and II trials were conducted in the United States, Colombia, Puerto Rico, Singapore and Thailand. Based on the 18-month data published in the journal Lancet Infectious Diseases, indicated that TAK-003 produced sustained antibody responses against all four virus strains, regardless of previous dengue exposure and dosing schedule.Data from the phase III trial, which began in September 2016, show that TAK-003 was efficacious against symptomatic dengue. TAK-003 appears to not lack efficacy in seronegative people or potentially cause them harm, unlike CYD-TDV. The data appear to show only moderate efficacy in other dengue serotypes than DENV2.In March 2021, the European Medicines Agency accepted the filing package for TAK-003 intended for markets outside of the EU. In development
TV-003/005
TV-003/005 is a tetravalent admixture of monovalent vaccines, that was developed by NIAID, that were tested separately for safety and immunogenicity. The vaccine passed Phase I trials and Phase II studies in US, Thailand, Bangladesh, India and Brazil.NIH has conducted Phase I and Phase II studies in over 1000 participants in the US.
Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.The safety and effectiveness of the vaccine was determined in three randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and the Asia Pacific region. The vaccine was determined to be approximately 76 percent effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals 9 through 16 years of age who previously had laboratory-confirmed dengue disease. Dengvaxia has already been approved in 19 countries and the European Union.Dengvaxia is not approved in the U.S. for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown.Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given six and twelve months later.The U.S. Food and Drug Administration (FDA) granted the application for Dengvaxia priority review designation and a tropical disease priority review voucher. The approval of Dengvaxia was granted to Sanofi Pasteur. CYD-TDV (Dengvaxia)
CYD-TDV, sold under the brand name Dengvaxia and made by Sanofi Pasteur, is a live attenuated tetravalent chimeric vaccine made using recombinant DNA technology by replacing the PrM (pre-membrane) and E (envelope) structural genes of the yellow fever attenuated 17D strain vaccine with those from the four dengue serotypes.