Dengue vaccine unit dose and administration thereof
a dengue and vaccine technology, applied in the direction of antibacterial agents, antibacterial medical ingredients, dsdna viruses, etc., can solve the problems of sudden high fever, debilitating and painful symptoms, nausea, vomiting and skin rashes,
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example 1
on of the Dengue Virus Strains
[1292]The methods used to generate the chimeric dengue strains TDV-1, -3 and -4 were standard molecular cloning and DNA engineering methods and are described in Huang et al. (2003) J. Virology 77(21): 11436-11447. The following well-known methods were used to construct and introduce the prM-E genes of dengue serotypes 1, 3 and 4 into the TDV-2 backbone: Reverse-transcriptase PCR (RT-PCR), PCR, restriction enzyme digestion, DNA fragment ligation, bacterial transformations by electroporation, plasmid DNA preparations, in vitro transcription by T7 RNA polymerase, and transfection of Vero cells by electroporation.
[1293]After growing and purifying the different dengue serotypes separately as described in Huang et al. (2013) PLOS Neglected Dis, 7(5):e2243, they are mixed in the concentrations provided in Table 5. The mixture of dengue serotypes is present in a dengue vaccine composition and combined with a composition of pharmaceutically acceptable excipients...
example 2
ralization Test
[1294]Immunogenicity was measured by a microneutralization assay to each one of the four dengue serotypes with titers defined as the dilution resulting in a 50% reduction in plaque values (MNT50). Briefly, on day 1 Vero cells were seeded on 96-well assay plates in DMEM and 10% FBS at a density of 2.5×105 cells / ml and incubated at 37° C. for 24 hours. On day 2 serial dilutions of the heat-inactivated antibody-containing test and control sera samples (dilutions range 1:10 to 1:20480) were prepared and mixed with a constant concentration of dengue viruses, in particular DENV-1 strain 16007, DENV-2 strain 16681, DENV-3 strain 16562 and DENV-4 strain 1036, (target 60-80 pfu / well) in a 96 well microtiter plate and incubated overnight at 2-8° C. to enable the neutralization of the virus by the antibodies present in the sera. After the incubation the mixture of virus and antibodies was transferred onto the 96 well plates with Vero cells and the plates were incubated at 37° C....
example 3
Trial Comparing Two Different Unit Doses
[1300]A descriptive Phase II, double-blind, randomized, and controlled trial in 351 subjects aged 21 to 45 years living in Singapore was performed comparing two different formulations of a tetravalent dengue vaccine. Subjects were randomized (1:1), stratified by baseline dengue serostatus, into two treatment groups: groups 1 received one subcutaneous (SC) dose of HD-TDV and group 2 received one subcutaneous dose of TDV. The dengue vaccine formulations were prepared as described in Example 1. The concentration of the four dengue serotypes in the HD-TDV vaccine (high dose tetravalent dengue vaccine) and in the TDV vaccine (corresponding to the unit dose of the invention as described herein) is outlined in Table 5.
TABLE 5Unit doses used in the trial.Comparative 0.5 mL comprising TDV-1, TDV-2, TDV-3 and TDV-4 containing 3.2 × 104 unit dosePFU, 1.3 × 105 PFU, 2.5 × 105 PFU, and 4 × 105 PFU, respectively. (HD-TDV)Administered by subcutaneous injecti...
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