TABLE 3.
CD8+ CTL Responses to Any HIV Antigen Detected via Chromium Release Assay at Day 98 or Day 182*
|
A. Cumulative | ||||
|---|---|---|---|---|
| Group | Observed Cumulative Response† | NPMLE Cumulative Response‡ | NPMLE Net Cumulative Response | 95% CI |
| A | 34/106 = 32% | 38% | 18% | (3% to 32%) |
| B | 16/47 = 34% | 45% | 24% | (5% to 43%) |
| C | 15/49 = 31% | 37% | 16% | (2% to 35%) |
| B and C | 31/96 = 32% | 40% | 20% | (6% to 35%) |
| D | 13/73 = 18% | 21% | n/a | n/a |
|
B. Point Prevalence | ||||
|---|---|---|---|---|
| Group | Day | Response | Net Response§ (95% CI) | |
| A | 98 | 23/87 = 26% | 14% (−2 to 30%) | |
| 182 | 15/77 = 19% | 9% (−7% to 26%) | ||
| B | 98 | 11/37 = 30% | 17% (−3% to 36%) | |
| 182 | 5/37 = 14% | 3% (−16% to 24%) | ||
| C | 98 | 8/42 = 19% | 6% (−13% to 26%) | |
| 182 | 7/38 = 18% | 8% (−11% to 28%) | ||
| B and C | 98 | 19/79 = 24% | 11% (−5% to 28%) | |
| 182 | 12/75 = 16% | 6% (−11 to 23%) | ||
| D | 98 | 8/63 = 13% | n/a | |
| 182 | 6/58 = 10% | n/a | ||
Indicates response to “any HIV antigen” is defined as a response to any of the Env-, Gag-, Pol-, or Nef-expressing recombinant vaccinia vectors used in the assay.
Observed cumulative response rates included any positive responses detected on day 98 and/or day 182.
Because traditional probabilities based on observed cumulative rates tend to be biased and underestimate response, standard optimization techniques were used to obtain NPMLEs of cumulative response rates.19
For each vaccine group, net point prevalence response rates were computed by subtracting the placebo group response rate and were considered to be statistically significant if the corresponding 95% CI did not include 0.
n/a indicates not applicable.