Table 5.
Seropositivity rates and GMTs for DENV neutralizing antibodies: Infant study (per protocol cohort)
| Group | Timing | N | n | % Seropositive (PRNT50 titer > 1:10) (95% CIs) | GMT (95% CIs) |
|---|---|---|---|---|---|
| Antibody: DENV-1 | |||||
| 1/10 dose | PD2 (month 7)* | 4 | 1 | 25.0 (0.6–80.6) | 6.1 (3.3–11.4) |
| PD2 (study year 1) | 4 | 0 | 0.0 (0.0–60.2) | 5.0 (5.0–5.0) | |
| PD2 (study year 3) | 4 | 0 | 0.0 (0.0–60.2) | 5.0 (5.0–5.0) | |
| 30 days PB (study year 3, days 30) | 4 | 2 | 50.0 (6.8–93.2) | 15.0 (1.3–179.1) | |
| 1 year PB (study year 4) | 4 | 1 | 25.0 (0.6–80.6) | 7.2 (2.2–23.5) | |
| Full dose | PD2 (month 7)* | 29 | 16 | 55.2 (35.7–73.6) | 20.7 (11.4–37.7) |
| PD2 (study year 1) | 30 | 7 | 23.3 (9.9–42.3) | 7.5 (5.5–10.2) | |
| PD2 (study year 3) | 28 | 12 | 42.9 (24.5–62.8) | 12.5 (7.7–20.1) | |
| 30 days PB (study year 3, days 30) | 28 | 24 | 85.7 (67.3–96.0) | 36.7 (22.7–59.2) | |
| 1 year PB (study year 4) | 29 | 14 | 48.3 (29.4–67.5) | 16.7 (9.1–30.5) | |
| Control | PD2 (month 7)* | 16 | 0 | 0.0 (0.0–20.6) | 5.0 (5.0–5.0) |
| PD2 (study year 1) | 15 | 1 | 6.7 (0.2–31.9) | 5.9 (4.1–8.6) | |
| Study year 4 | 15 | 1 | 6.7 (0.2–31.9) | 5.6 (4.4–7.3) | |
| Antibody: DENV-2 | |||||
| 1/10 dose | PD2 (month 7)* | 4 | 4 | 100 (39.8–100) | 173.6 (50.1–601.5) |
| PD2 (study year 1) | 4 | 3 | 75.0 (19.4–99.4) | 16.3 (2.3–113.3) | |
| PD2 (study year 3) | 4 | 2 | 50.0 (6.8–93.2) | 12.8 (2.2–73.7) | |
| 30 days PB (study year 3, days 30) | 4 | 4 | 100 (39.8–100) | 121.3 (18.5–794.4) | |
| 1 year PB (study year 4) | 4 | 3 | 75.0 (19.4–99.4) | 23.6 (3.1–183.0) | |
| Full dose | PD2 (month 7)* | 28 | 28 | 100 (87.7–100) | 239.6 (163.6–351.1) |
| PD2 (study year 1) | 30 | 28 | 93.3 (77.9–99.2) | 28.4 (20.8–38.6) | |
| PD2 (study year 3) | 28 | 18 | 64.3 (44.1–81.4) | 18.1 (11.8–27.7) | |
| 30 days PB (study year 3, days 30) | 29 | 29 | 100 (88.1–100) | 162.3 (121.1–217.4) | |
| 1 year PB (study year 4) | 29 | 29 | 100 (88.1–100) | 116.0 (80.2–167.8) | |
| Control | PD2 (month 7)* | 16 | 0 | 0.0 (0.0–20.6) | 5.0 (5.0–5.0) |
| PD2 (study year 1) | 14 | 0 | 0.0 (0.0–23.2) | 5.0 (5.0–5.0) | |
| Study year 4 | 15 | 3 | 20.0 (4.3–48.1) | 9.4 (4.3–20.2) | |
| Antibody: DENV-3 | |||||
| 1/10 dose | PD2 (month 7)* | 4 | 0 | 0.0 (0.0–60.2) | 5.0 (5.0–5.0) |
| PD2 (study year 1) | 4 | 0 | 0.0 (0.0–60.2) | 5.0 (5.0–5.0) | |
| PD2 (study year 3) | 4 | 1 | 25.0 (0.6–80.6) | 6.6 (2.7–15.8) | |
| 30 days PB (study year 3, days 30) | 4 | 4 | 100 (39.8–100) | 19.0 (11.7–31.1) | |
| 1 year PB (study year 4) | 4 | 2 | 50.0 (6.8–93.2) | 9.1 (3.0–27.2) | |
| Full dose | PD2 (month 7)* | 29 | 25 | 86.2 (68.3–96.1) | 29.2 (18.6–45.7) |
| PD2 (study year 1) | 30 | 7 | 23.3 (9.9–42.3) | 7.8 (5.5–11.0) | |
| PD2 (study year 3) | 28 | 9 | 32.1 (15.9–52.4) | 8.9 (6.2–12.6) | |
| 30 days PB (study year 3, days 30) | 28 | 25 | 89.3 (71.8–97.7) | 28.3 (18.3–44.0) | |
| 1 year PB (study year 4) | 29 | 20 | 69.0 (49.2–84.7) | 19.6 (11.8–32.7) | |
| Control | PD2 (month 7)* | 16 | 0 | 0.0 (0.0–20.6) | 5.0 (5.0–5.0) |
| PD2 (study year 1) | 15 | 1 | 6.7 (0.2–31.9) | 5.5 (4.5–6.7) | |
| Study year 4 | 15 | 4 | 26.7 (7.8–55.1) | 8.2 (4.6–14.7) | |
| Antibody: DENV-4 | |||||
| 1/10 dose | PD2 (month 7)* | 4 | 3 | 75.0 (19.4–99.4) | 31.9 (2.5–408.2) |
| PD2 (study year 1) | 4 | 1 | 25.0 (0.6–80.6) | 9.8 (1.1–84.9) | |
| PD2 (study year 3) | 4 | 1 | 25.0 (0.6–80.6) | 12.2 (0.7–210.7) | |
| 30 days PB (study year 3, days 30) | 4 | 3 | 75.0 (19.4–99.4) | 27.1 (2.5–288.9) | |
| 1 year PB (study year 4) | 4 | 1 | 25.0 (0.6–80.6) | 14.7 (0.5–451.5) | |
| Full dose | PD2 (month 7)* | 28 | 27 | 96.4 (81.7–99.9) | 52.5 (29.0–95.0) |
| PD2 (study year 1) | 30 | 13 | 43.3 (25.5–62.6) | 13.4 (8.1–22.4) | |
| PD2 (study year 3) | 29 | 14 | 48.3 (29.4–67.5) | 16.6 (9.4–29.3) | |
| 30 days PB (study year 3, days 30) | 29 | 29 | 100 (88.1–100) | 77.0 (50.9–116.5) | |
| 1 year PB (study year 4) | 29 | 24 | 82.8 (64.2–94.2) | 36.8 (23.3–58.2) | |
| Control | PD2 (month 7)* | 16 | 0 | 0.0 (0.0–20.6) | 5.0 (5.0–5.0) |
| PD2 (study year 1) | 15 | 1 | 6.7 (0.2–31.9) | 7.0 (3.4–14.4) | |
| Study year 4 | 15 | 2 | 13.3 (1.7–40.5) | 6.1 (4.5–8.3) | |
CIs = confidence intervals; DENV = dengue virus; GMT = geometric mean antibody titer calculated on all subjects; N = number of subjects with available results; n/% = number/percentage of subjects with titer above the assay cutoff; PB = post booster; PD2 = post dose 2; PRNT50 = plaque-reduction neutralization test.
*
PD2 (month 7) data from primary study.