Table 3.
Antibody Responses for the HIV-Infected PCV and HIV-Uninfected PCV 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 | HIV+ | HIV− | HIV+ | HIV− | HIV+ HIV− | HIV+ HIV− | HIV+ HIV− | HIV+ HIV− | ||||
| 14 | 67 (54) | 22 (92) | 37 (30) | 16 (67) | 54 (43) | 17 (71) | 68 (54) | 22 (92) | 57 (46) | 18 (75) | 37 (30) | 14 (58) |
| 60 | 68 (57) | 22 (88) | 37 (31) | 16 (64) | 48 (40) | 18 (72) | 63 (53) | 21 (84) | 61 (51) | 18 (72) | 42 (35) | 20 (80) |
| 180 | 47 (41) | 21 (84) | 26 (22) | 16 (64) | 37 (32) | 18 (72) | 49 (42) | 22 (88) | 47 (41) | 18 (72) | 38 (33) | 12 (48) |
| Adjusted Odds Ratios for a Positive Immune Response (HIV-Infected to HIV-Uninfected) 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 | 0.1 (0.0, 0.7) 0.01 | 0.3 (0.1, 0.7) 0.01 | 0.4 (0.2, 1.2) 0.09 | 0.1 (0.0, 0.60) 0.01 | 0.5 (0.2, 1.5) 0.20 | 0.3 (0.1, 0.8) 0.02 | ||||||
| 60 | 0.2 (0.1, 0.7) 0.01 | 0.3 (0.1, 0.8) 0.01 | 0.3 (0.1, 0.7) 0.008 | 0.2 (0.1, 0.7) 0.01 | 0.8 (0.3, 2.3) 0.67 | 0.1 (0.0, 0.4) <0.001 | ||||||
| 180 | 0.1 (0.0, 0.4) <0.001 | 0.2 (0.1, 0.4) <0.001 | 0.2 (0.1, 0.4) <0.001 | 0.1 (0.0, 0.4) <0.001 | 0.4 (0.1, 1.1) 0.08 | 0.5 (0.2, 1.3) 0.17 | ||||||
| Adjusted Differences (HIV-Infected PCV–HIV-Uninfected PCV) 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 | −0.37 (−0.64, −0.10) 0.008 | −0.64 (−0.90, −0.38) <0.001 | −0.46 (−0.76, −0.16) 0.003 | −0.50 (−0.76, −0.23) <0.001 | ||||||||
| 60 | −0.69 (−0.97, −0.41) <0.001 | −0.58 (−0.83, −0.33) <0.001 | −0.48 (−0.79, −0.17) 0.002 | −0.69 (−0.93, −0.45) <0.001 | ||||||||
| 180 | −0.53 (−0.77, −0.29) <0.001 | −0.66 (−0.90, −0.42) <0.001 | −0.46 (−0.74, −0.18) 0.002 | −0.48 (−0.73, −0.24) <0.001 | ||||||||
1
Primary endpoint: positive immune response to at least 2 of 4 serotypes at day 60