Table 2. Anti-Sm-TSP-2 total IgG geometric mean levels (Arbitrary Units) and seroresponse results, by time point and vaccine group (per-protocol immunogenicity population).
| Time Point | 10μg Sm-TSP-2/Alhydrogel (N = 8) |
10μg Sm-TSP-2/Alhydrogel with AP 10–701 (N = 8) |
30μg Sm-TSP-2/Alhydrogel (N = 8) |
30μg Sm-TSP-2/Alhydrogel with AP 10–701 (N = 8) |
100μg Sm-TSP-2/Alhydrogel (N = 8) |
100μg Sm-TSP-2/Alhydrogel with AP 10–701 (N = 8) |
Euvax B Vaccine (N = 12) |
|
|---|---|---|---|---|---|---|---|---|
| Day 1 (Vax #1) | n | 8 | 8 | 8 | 8 | 8 | 8 | 12 |
| GML (95% CI) | 2.2 (1.0, 4.6) | 2.3 (1.0, 5.2) | 1.7 (1.0, 3.1) | 2.0 (0.9, 4.3) | 2.6 (1.3, 5.2) | 2.4 (1.2, 4.9) | 3.7 (2.2, 6.2) | |
| GMFR (95% CI) | - | - | - | - | - | - | - | |
| Number (%) Respondersa | - | - | - | - | - | - | - | |
| Day 15 | n | 8 | 8 | 8 | 8 | 8 | 8 | 12 |
| GML (95% CI) | 4.3 (0.7, 28.3) | 2.6 (0.9, 7.3) | 2.6 (1.0, 7.0) | 3.3 (1.0, 11.0) | 4.1 (1.3, 12.7) | 7.3 (3.5, 15.2) | 3.2 (1.9, 5.5) | |
| GMFR (95% CI) | 2.0 (0.5, 8.1) | 1.2 (0.9, 1.4) | 1.5 (0.7, 3.0) | 1.7 (0.8, 3.4) | 1.6 (0.9, 3.0) | 3.0 (1.3, 6.9) | 0.9 (0.7, 1.1) | |
| Number (%) Respondersa | 1 (13) | 0 | 1 (13) | 1 (13) | 1 (13) | 3 (38) | 0 | |
| Day 57 (Vax #2) | n | 8 | 8 | 8 | 8 | 8 | 8 | 12 |
| GML (95% CI) | 4.1 (0.6, 26.2) | 3.9 (1.2, 12.4) | 3.1 (1.2, 7.9) | 2.8 (1.0, 7.7) | 3.0 (1.2, 7.7) | 5.9 (3.1, 11.1) | 36 (2.2, 5.9) | |
| GMFR (95% CI) | 1.8 (0.4, 7.7) | 1.7 (0.7, 4.1) | 1.8 (0.9, 3.7) | 1.4 (0.9, 2.2) | 1.2 (0.6, 2.1) | 2.4 (1.1, 5.3) | 1.0 (0.9, 1.1) | |
| Number (%) Responders | 1 (13) | 1 (13) | 2 (25) | 0 | 0 | 3 (38) | 0 | |
| Day 71 | n | 8 | 7 | 8 | 8 | 8 | 7 | 12 |
| GML (95% CI) | 3.4 (0.8, 14.2) | 2.9 (1.2, 7.3) | 2.6 (1.0, 7.0) | 7.3 (2.6, 20.4) | 6.3 (2.2, 18.3) | 11.6 (3.8, 35.6) | 3.6 (2.3, 5.8) | |
| GMFR (95% CI) | 1.5 (0.6, 4.0) | 1.3 (0.7, 2.7) | 1.5 (0.7, 3.1) | 3.7 (1.5, 9.1) | 2.4 (1.2, 4.9) | 4.3 (1.9, 9.9) | 1.0 (0.9, 1.1) | |
| Number (%) Responders | 1 (13) | 1 (14) | 1 (13) | 4 (50) | 2 (25) | 4 (57) | 0 | |
| Day 113 (Vax #3) | n | 8 | 6 | 8 | 8 | 8 | 7 | 12 |
| GML (95% CI) | 3.0 (0.9, 10.6) | 3.7 (0.9, 15.0) | 2.6 (1.0, 6.9) | 3.5 (1.2, 9.9) | 5.5 (2.2, 13.4) | 10.8 (3.8, 30.3) | 3.4 (2.2, 5.2) | |
| GMFR (95% CI) | 1.4 (0.6, 3.0) | 1.5 (0.8, 2.7) | 1.5 (0.8, 3.1) | 1.8 (1.0, 3.2) | 2.1 (1.3, 3.4) | 4.1 (1.6, 10.0) | 0.9 (0.8, 1.1) | |
| Number (%) Responders | 1 (13) | 1 (17) | 1 (13) | 1 (13) | 1 (13) | 2 (29) | 0 | |
| Day 127 | n | 8 | 6 | 7 | 8 | 8 | 7 | 12 |
| GML (95% CI) | 3.4 (1.0, 11.3) | 8.3 (3.1, 22.2) | 7.3 (2.3, 23.1) | 10.0 (5.1, 19.8) | 6.1 (1.6, 23.6) | 25.0 (5.1, 123.1) | 3.8 (2.2, 6.7) | |
| GMFR (95% CI) | 1.5 (0.7, 3.4) | 3.4 (2.1, 5.5) | 3.4 (1.1, 10.3) | 5.1 (3.0, 8.7) | 2.4 (0.8, 6.9) | 9.4 (3.4, 25.7) | 1.0 (0.8, 1.4) | |
| Number (%) Responders | 1 (13) | 2 (33) | 2 (25) | 4 (50) | 2 (25) | 6 (86) | 1 (8) | |
| Day 203 | n | 8 | 6 | 7 | 7 | 7 | 7 | 12 |
| GML (95% CI) | 3.2 (1.2, 8.9) | 3.8 (1.0, 14.8) | 3.8 (1.3, 10.8) | 5.9 (2.3, 15.2) | 7.2 (3.3, 15.4) | 22.6 (11.9, 42.9) | 3.5 (2.2, 5.4) | |
| GMFR (95% CI) | 1.5 (0.8, 2.9) | 1.5 (0.8, 3.1) | 1.9 (0.9, 4.2) | 2.8 (1.5, 5.3) | 3.1 (1.3, 7.2) | 8.5 (4.3, 16.8) | 0.9 (0.8, 1.2) | |
| Number (%) Responders | 2 (25) | 1 (17) | 2 (25) | 2 (29) | 3 (43) | 5 (71) | 0 | |
| Day 293 | n | 8 | 6 | 7 | 7 | 6 | 7 | 12 |
| GML (95% CI) | 3.3 (1.2, 8.8) | 3.5 (0.9, 13.0) | 3.2 (1.3, 8.3) | 4.2 (1.5, 11.8) | 4.8 (2.3, 10.1) | 16.2 (8.4, 31.0) | 3.7 (2.4, 5.8) | |
| GMFR (95% CI) | 1.5 (0.8, 2.9) | 1.4 (0.8, 2.6) | 1.7 (0.9, 3.2) | 2.0 (1.1, 3.8) | 2.6 (1.1, 5.7) | 6.1 (2.9, 12.6) | 1.0 (0.8, 1.3) | |
| Number (%) Responders | 2 (25) | 1 (17) | 1 (13) | 1 (14) | 3 (50) | 4 (57) | 0 | |
| Day 478 | n | 6 | 6 | 7 | 6 | 7 | 7 | 10 |
| GML (95% CI) | 3.1 (0.9, 10.7) | 3.4 (1.0, 12.1) | 2.7 (1.0, 7.1) | 4.1 (1.3, 12.4) | 4.2 (2.3, 7.8) | 11.4 (6.2, 20.9) | 3.8 (2.4, 6.0) | |
| GMFR (95% CI) | 1.4 (0.7, 2.9) | 1.4 (0.8, 2.5) | 1.4 (0.7, 2.7) | 1.8 (0.8, 3.7) | 1.8 (0.8, 3.9) | 4.1 (2.2, 7.7) | 0.9 (0.7, 1.3) | |
| Number (%) Responders | 0 | 1 (17) | 1 (13) | 1 (17) | 2 (29) | 4 (57) | 0 |
Note: N = Number of participants in the per-protocol immunogenicity population. n = Number of participants with results at the given timepoint. CI = confidence interval. GML = Geometric mean level. SD = standard deviation. GMFR = Geometric mean fold rise in antibody level compared to baseline.
aParticipants were considered to have a positive antibody response if the fold rise from baseline was at least 4.0.