Table 1.
Study |
US |
Thailand |
Puerto Rico |
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adults |
Adults |
Child (< 12 yoa) |
Adult/Adolescent(≥ 12 yoa) |
All |
||||||||||||
total |
primed# |
total |
primed* |
total |
primed# |
total |
primed# |
total |
primed# |
|||||||
Subjects | Treatment | N | n | % | N | n | % | N | n | % | N | n | % | N | n | % |
ATP cohort | F17/Pre | 20 | 4 | 20 | - | - | - | - | - | - | - | - | - | - | ||
F17 | 20 | 4 | 20 | 39 | 34 | 87 | 27 | 14 | 52 | 19 | 16 | 84 | 177 | 91 | 51 | |
F19 | 18 | 3 | 17 | 39 | 38 | 97 | 28 | 10 | 36 | 16 | 14 | 88 | 155 | 94 | 61 | |
Placebo | 19 | 3 | 16 | 40 | 37 | 93 | 29 | 15 | 52 | 16 | 15 | 94 | 175 | 101 | 58 | |
Total | 77 | 14 | 18 | 118 | 109 | 92 | 84 | 39 | 46 | 51 | 45 | 88 | 507 | 286 | 56 | |
T-cell analysis (ICS@) | F17/Pre | 20 | 4 | 20 | - | - | - | - | - | - | - | - | - | - | ||
F17 | 19 | 4 | 21 | 24 | 23 | 96 | 22 | 11 | 50 | 11 | 9 | 82 | 33 | 20 | 61 | |
F19 | 17 | 3 | 18 | 22 | 21 | 96 | 23 | 7 | 30 | 12 | 10 | 83 | 35 | 17 | 49 | |
Placebo | 19 | 3 | 16 | 23 | 22 | 96 | 21 | 14 | 67 | 11 | 10 | 91 | 32 | 24 | 75 | |
Total | 75 | 14 | 19 | 69 | 66 | 96 | 66 | 32 | 49 | 34 | 29 | 85 | 100 | 61 | 61 | |
B-cell analysis | F17/Pre | 18 | 3 | 17 | - | - | - | - | - | - | - | - | - | - | - | |
F17 | 19 | 4 | 21 | 12 | - | - | - | - | - | 18 | 15 | 83 | - | - | - | |
F19 | 15 | 2 | 13 | 8 | - | - | - | - | - | 15 | 14 | 93 | - | - | - | |
Placebo | 17 | 3 | 18 | - | - | - | - | - | - | 15 | 14 | 93 | - | - | - | |
Total | 69 | 12 | 17 | 20 | - | - | - | - | - | 48 | 43 | 90 | - | - | - |
ATP, according to protocol. yoa, years of age. ICS, intracellular cytokine staining. N, number of subjects with available results for the respective analysis at baseline (numbers may vary by the DENV serotype analysed). #Seropositivity rate to DENV was defined as the percentage of subjects with neutralizing antibody (nAb) titers to at least one DENV serotype ≥ 1:10 dilution at pre-vaccination. *Seropositivity rate to DENV or Japanese encephalitis virus (JEV) was defined as the percentage of subjects with nAb titers to at least one DENV serotype or JEV ≥ 1:10 dilution at pre-vaccination. @Numbers are indicated for the ICS assay using infected cell lysates, the ICS assay using peptide-pool stimulation and the IFN-γ ELISPOT assay described in the current report were performed for 15 US subjects (of whom 13 were vaccinated) and 13 US subjects (of whom 11 were vaccinated), respectively.