Table 3. Response Rates (Confidence Limits) and Seroprotection Rates (Confidence Limits) after One and Two Doses of MCV4 for 2-10 Year-old Participants with data for Weeks 4 and 28 (Current Report) Compared to 11-24 Year-old Participants (Earlier P1065 Cohort) with HIV Infection and 2-10 Year-Old Participants without HIV Infection.
| After First MCV4 Dose (Week 4) | After Second MCV4 Dose (Week 28) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Study Cohort | A | C | W-135 | Y | A | C | W-135 | Y | |
| 2-10 yrs, HIV-infected (current cohort)1 | All (n=49) | 92 (80, 98) | 43 (29, 58) | 98 (89, >99) | 76 (61, 87) | 88 (75, 95) | 80 (66, 90) | 100 (93, 100) | 84 (70, 93) |
| Entry titer <1:8 | 95 (83, 99) n=39 |
43 (28,59) n=42 |
100 (91, 100) n=37 |
100 (74, 100) n=12 |
95 (83, 99) n=39 |
86 (71, 95) n=42 |
100 (91, 100) n=37 |
100 (74, 100) n=12 |
|
| VL<400 (n=34) | 91 (76, 98) | 44 (27, 62) | 100 (90, 100) | 76 (59, 89) | 85 (69, 95) | 85 (69, 95) | 100 (90, 100) | 88 (73, 97) | |
|
| |||||||||
| Seroprotection | 96 (86, >99) | 49 (34, 64) | 98 (89, >99) | 90 (78, 97) | 96 (86, >99) | 80 (66, 90) | 100 (93, 100) | 98 (89, >99) | |
|
| |||||||||
| 11-24 yrs, HIV-infected (previous cohort)2 | CD4%≥25, 2-Dose Group | 85 (74, 92) n=65 |
66 (53, 77) n=65 |
88 (78, 95) n=66 |
76 (64, 85) n=66 |
86 (75, 93) n=63 |
75 (63, 85) n=65 |
92 (83, 97) n=66 |
82 (70, 90) n=66 |
| Seroprotection | 95 (87, 99) n=66 |
64 (51, 75) n=66 |
83 (72, 91) n=66 |
79 (67, 88) n=66 |
95 (87, 99) n=64 |
68 (56, 79) n=66 |
91 (81, 97) n=66 |
88 (78, 95) n=66 |
|
|
| |||||||||
| 2-10 yrs, Healthy3 | All | 99 (96, 100) n=279 |
88 (84, 91) n=338 |
96 (94, 98) n=400 |
86 (77, 93) n=87 |
- | - | - | - |
|
| |||||||||
| Seroprotection | 97 (95, 100) | 81 (78,100) | 91 (88, 100) | 93 (90, 100) | - | - | - | - | |
1
All participants in 2-10 year-old cohort were required to have CD4%≥25% at baseline.
2
Older cohort results presented for comparison[Ref # 12].
3
Results from study of single MCV4 dose in healthy (HIV-uninfected) 2-10 year-old study presented for comparison; all with pre-vaccine rSBA titer <8) [Ref # 18].