Table 2.
Antibody Responses for the HIV-Infected PCV and PPV Arms
At Least 2 of 4 Serotypes | At least 3 of 4 Serotypes | Serotype 4 | Serotype 9V | Serotype 14 | Serotype 19F | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
N (%) With a Positive Immune Response1 | ||||||||||||
Day | PCV | PPV | PCV | PPV | PCV | PPV | PCV PPV | PCV PPV | PCV PPV | |||
14 | 67 (54) | 23 (35) | 37 (30) | 11 (17) | 54 (43) | 17 (26) | 68 (54) | 22 (33) | 57 (46) | 27 (41) | 37 (30) | 12 (18) |
60 | 68 (57) | 23 (36) | 37 (31) | 9 (14) | 48 (40) | 15 (23) | 63 (53) | 25 (39) | 61 (51) | 28 (44) | 42 (35) | 12 (19) |
180 | 47 (41) | 20 (31) | 26 (22) | 11 (17) | 37 (32) | 16 (25) | 49 (42) | 24 (38) | 47 (41) | 22 (34) | 38 (33) | 13 (20) |
Adjusted Odds Ratios for a Positive Immune Response (PCV to PPV) With 95% Confidence Intervals and P-values | ||||||||||||
Day | OR (95% CI) p-value | OR (95% CI) p-value | OR (95% CI) p-value | OR (95% CI) p-value | OR (95% CI) p-value | OR (95% CI) p-value | ||||||
14 | 2.4 (1.2, 4.6) 0.009 | 2.2 (1.0, 4.9) 0.05 | 2.4 (1.2, 4.7) 0.01 | 2.5 (1.3, 4.8) 0.007 | 1.3 (0.7, 2.5) 0.39 | 1.9 (0.9, 4.1) 0.09 | ||||||
60 | 2.6 (1.4, 5.0) 0.004 | 2.6 (1.1, 6.0) 0.02 | 2.3 (1.1, 4.7) 0.02 | 1.7 (0.9, 3.1) 0.12 | 1.5 (0.8, 3.0) 0.19 | 3.5 (1.5, 7.9) 0.004 | ||||||
180 | 1.4 (0.7, 2.7) 0.34 | 1.3 (0.6, 2.9) 0.55 | 1.4 (0.7, 2.8) 0.36 | 1.1 (0.6, 2.1) 0.80 | 1.3 (0.7, 2.6) 0.39 | 1.8 (0.9, 3.8) 0.12 | ||||||
Adjusted Differences (PCV-PPV) for Change from Baseline in IgG Concentration (log10 ng/mL) With 95% Confidence Intervals and P-values | ||||||||||||
Day | Difference (CI) p-value | Difference (CI) p-value | Difference (CI) p-value | Difference (CI) p-value | ||||||||
14 | 0.31 (0.15, 0.48) <0.001 | 0.19 (0.03, 0.35) 0.02 | 0.07 (−0.11, 0.25) 0.43 | 0.10 (−0.06, 0.26) 0.23 | ||||||||
60 | 0.21 (0.04, 0.38) 0.02 | 0.17 (0.01, 0.32) 0.04 | 0.14 (−0.05, 0.34) 0.14 | 0.19 (0.03, 0.34) 0.02 | ||||||||
180 | 0.14 (−0.01, 0.29) 0.07 | 0.05 (−0.11, 0.21) 0.55 | 0.11 (−0.07, 0.28) 0.23 | 0.13 (−0.01, 0.28) 0.08 |
Primary endpoint: positive immune response to at least 2 of 4 serotypes at day 60