Table 4.
Application of the Proposed Sequential Design to the Past HIV Vaccine Efficacy Trials.
| Total Randomized and HIV Negative at Baseline | Total Reached Month 6 Visit | Number Infections Diagnosed in First 18 Months | ||||||
|---|---|---|---|---|---|---|---|---|
| Trial | Actual Trial | At Boundary Proposed Design | Actual Trial | At Boundary Proposed Design | Time First Analysis Proposed Design | Total Actual Trial | At First Analysis Proposed Design | At Boundary Proposed Design |
| Vax004 | 5,403 | 5,403 (100%) |
5,403 (100%) |
5,107 (94%) |
1 yr 7mo |
171 | 65 | 155 (69V: 86P) |
| Vax003 | 2,527 | 2,527 (100%) |
2,527 (100%) |
2019 (80%) |
1 yr 8 mo |
104 | 65 | 65 (37V: 28P) |
| Step | 1,836 | 1,771 (96%) |
1,836 (100%) |
1191 (65%) |
2 yrs 1 mo |
67 | 65 | 65 (40V: 25P) |
| RV144 | 16,395 | 16,395 (100%) |
16,395 (100%) |
16,165 (99%) |
3 yrs 1 mo |
67 | 65 | Not Crossed |
| Trial Duration | Trial Result | ||||
|---|---|---|---|---|---|
| Trial | Analysis of Boundary Crossing | Actual Trial | Proposed Design | Actual Trial Est. VE(0-18), 95% CI, 2-sided p-value | Proposed Design Est. VE(0-18), 95% CI, 2-sided p-value |
| Vax004 | 7th | 4 yrs 6 mos |
2 yrs 5 mos |
10%, -20% to 33%, p=0.48 |
24%, -5% to 46%, p=0.09 |
| Vax003 | 1st | 4 yrs 6 mos |
1 yr 8 mo |
1.03, 0.67 to 1.4, p=0.87 |
1.35*, 0.81 to 2.21, p=0.24 |
| Step | 1st | 2 yrs 10 mos |
2 yrs 1 mo |
1.47, 0.95 to 2.28, p=0.08 |
1.58*, 0.90 to 2.61, p=0.10 |
| RV144 | Not Crossed |
5 yrs 0 mos |
5 yrs 0 mos |
44%, 8% to 66%, p=0.02 |
49%, 32% to 82%, p=0.006 |
*
Reported as Est. HR(0-18) and 95% CI for HR(0-18)