Fig 1.
CONSORT diagram of enrollment and follow up of subjects for first and second dosings of TV003 in subjects who were flavivirus-exposed prior to vaccination with TV003 (Study CIR280).
The schedule of blood draws for serological and virological testing is indicated in the shaded box at right.
Table 1.
Adverse events following first and second dose of TV003 in flavivirus-experienced individuals.
Table 2.
Viremia following the first dose of TV003 in flavivirus-experienced subjects (n = 41)a.
Fig 2.
Mean plaque reduction (50%) neutralizing titers (PRNT50) for DENV-1 (A), DENV-2 (B), DENV-3 (C), and DENV-4 (D) following one or two doses of TV003 in flavivirus-experienced subjects (n = 41 for Dose 1, and n = 33 for Dose 2). All data represent mean titers (GMT) ± 95% confidence interval. Dotted line indicates seropositivity (PRNT50 ≥ 1:10) and gray area represents the range of Ab levels to each serotype observed in subjects who received placebo (n = 17 for dose 1 and n = 15 for Dose 2).
Table 3.
Mean peak neutralizing antibody titers to TV003 in subjects who were flavivirus-experienced or -naïvea prior to vaccination.
Table 4.
Reciprocal mean neutralizing antibody titers 6 months after dose 1 (Day 180) and dose 2 (Day 360) after vaccination with TV003 of subjects who were either flavivirus-experienced or–naïvea at time of first vaccination.
Fig 3.
Mean peak neutralizing antibody titers (PRNT50) for DENV-1(A), DENV-2 (B), DENV-3 (C), and DENV-4 (D) up to 90 days following one dose of TV003 in flavivirus-naïve subjects (n = 58, from ref. [19]), all flavivirus-experienced (all FV+) subjects (n = 38) and by two subgroups–those with yellow fever virus (YF+, n = 31) or dengue virus exposure (Dengue, n = 11). All data represent mean titers (GMT) ± 95% confidence interval. Statistical significance of the difference between FV-naïve group was assessed by one-way ANOVA with Sidak correction for multiple comparisons. *, P < 0.05, **, P < 0.01, *** P, < 0.001.
Table 5.
Frequency of seropositivity to each DENV serotype after one or two doses of TV003 in subjects who were flavivirus-experienced or -naïvea prior to vaccination.
Table 6.
Valency of DENV responses after one or two doses of TV003 in subjects who were flavivirus-experienced or -naïvea prior to vaccination.