Article Figures & Data
Figures
- FIG 1
hSBA titers of serum samples determined using independent pooled human complement (hC′) lots. Two-fold serum dilutions from 1:4 to 1:1,024 were tested. Titers of <4 are shown as values of 2. (A) Comparison of hSBA titers for 15 samples using hC′ lots C12, C13, and C14 analyzed in the CBER laboratory; data for 3 samples tested with lot C11 are included. Indeterminate titers (n = 2) and titers of ≥64 with insufficient sample to test at higher dilutions (n = 2) are not shown. (B) Comparison of reported titers for 18 samples tested using hC′ lots C11, C12, and C13 in the PHE laboratory. Two samples with data available for only one hC′ lot are not shown. (C) Comparison of the median values of 14 samples between the CBER and PHE laboratories. Sample 33005 is not shown, as a valid median titer (panel B) was not determined.
- FIG 2
The hSBA geometric mean titers (GMTs) are shown by vaccination group at 28 days and 10 months after primary immunization (H, Hib; M, PsACWY; P, PsA-TT). For groups that received a second meningococcal immunization, GMTs are shown at 28 days after the second immunization and at 2 years postenrollment. The first letter designates the first immunization, and the second letter designates the second immunization. Error bars show ±1 standard deviation.
- FIG 3
Reverse cumulative distribution curves for hSBA responses to PsA-TT vaccination. Shown is the proportion of subjects with hSBA titers at or above the x axis value for the PsA-TT primary immunization group at 28 days (P 1 mo) and 10 months (P 10 mo) after primary immunization, PsA-TT-primed subjects who received a second PsA-TT dose (PP) or a one-fifth dose of PsACWY challenge (PM) at 28 days (PP 11 mo or PM 11 mo, respectively) and 14 months (PP 24 mo or PM 24 mo, respectively) after the second immunization. The distribution of hSBA titers among the reference PsACWY vaccine group is shown at 28 days after primary immunization (M 1 mo).
Tables
- TABLE 1
Proportion of subjects with hSBA titers of ≥8 in the intention-to-treat population
Primary vaccine Secondary vaccine No. of subjects with titers of ≥8/total no. of subjects; % (95% CI) 28 days after primary 10 mo after primary 28 days after 2nd vaccined 14 mo after 2nd vaccined PsA-TT 42/57; 73.7a (60.3, 84.5) 11/55; 20.0b (10.4, 33.0) PsA-TT 11/13; 84.6 (54.6, 98.1) 12/15; 80.0 (51.9, 95.7) PsACWY 22/22; 100.0 (84.6, 100.0) 16/22; 72.7 (49.8, 89.3) Hib 3/18; 16.7 (3.6, 41.4) 4/19; 21.1 (6.1, 45.6) PsACWY 20/61; 32.8c (21.3, 46.0) 1/61; 1.6 (0.0, 8.8) PsA-TT 13/19; 68.4 (43.4, 87.4) 7/20; 35.0 (15.4, 59.2) PsACWY 9/17; 52.9 (27.8, 77.0) 5/18; 27.8 (9.7, 53.5) Hib 2/21; 9.5 (1.2, 30.4) 8/22; 36.4 (17.2, 59.3) Hib 8/62; 13.1 (5.8, 24.2) 3/59; 5.1 (1.1, 14.1) PsA-TT 6/16; 37.5 (15.2, 64.6) 5/16; 31.3 (11.0, 58.7) PsACWY 4/22; 18.2 (5.2, 40.3) 3/20; 15.0 (3.2, 37.9) Hib 1/18; 5.6 (0.1, 27.3) 4/19; 26.3 (9.1, 51.2) ↵a Fisher's exact test of percentage of subjects with titers of ≥8, P < 0.0001 for PsA-TT compared to PsACWY and compared to Hib at 28 days after primary immunization.
↵b Fisher's exact test of percentage of subjects with titers of ≥8, P = 0.0014 for PsA-TT compared to PsACWY, and P = 0.0212 for PsA-TT compared to Hib at 10 months after primary immunization.
↵c Fisher's exact test of percentage of subjects with titers of ≥8, P = 0.0169 for PsACWY compared to Hib at 28 days after primary immunization.
↵d No significance testing performed.
Supplemental material
Files in this Data Supplement:
- Supplemental file 1 -
Table S1. Demographic and serologic characteristics of 100 adult blood donor sera and selected subsets used for pooled human complement. Fig. S1. Serologic characteristics of adult blood donor sera screened as complement sources. Fig. S2. PsA-TT study in African toddlers 12 to 23 months of age.
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- Supplemental file 1 -
