Table 2. Efficacy of the RTS,S/AS01E Vaccine against Episodes of Clinical Malaria.*.
| Episode | RTS,S/AS01E Vaccine | Rabies Vaccine | Adjusted Efficacy | Unadjusted Efficacy | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of Subjects |
No. of Episodes |
Person-Yr at Risk |
Event Rate |
No. of Subjects |
No. of Episodes |
Person-Yr at Risk |
Event Rate |
% (95% CI) | P Value | % (95% CI) | P Value | ||
| According-to-protocol analysis | |||||||||||||
| First or only episode | |||||||||||||
| >2500 parasites/μl | 402 | 32 | 245 | 0.13 | 407 | 66 | 239 | 0.28 | 53 (28–69) | <0.001 | 55 (31–70) | <0.001 | |
| >0 parasites/μl | 402 | 33 | 245 | 0.13 | 407 | 70 | 237 | 0.30 | 55 (31–70) | <0.001 | 57 (34–71) | <0.001 | |
| All multiple episodes | |||||||||||||
| >2500 parasites/μl | 402 | 38 | 254 | 0.15 | 407 | 86 | 255 | 0.34 | 56 (31–72) | <0.001 | 58 (34–73) | <0.001 | |
| >0 parasites/μl | 402 | 40 | 254 | 0.16 | 407 | 94 | 255 | 0.37 | 58 (35–73) | <0.001 | 60 (37–74) | <0.001 | |
| Intention-to-treat analysis | |||||||||||||
| First or only episode | |||||||||||||
| >2500 parasites/μl | 447 | 42 | 351 | 0.12 | 447 | 78 | 339 | 0.23 | 49 (26–65) | <0.001 | |||
| >0 parasites/μl | 447 | 47 | 349 | 0.13 | 447 | 81 | 337 | 0.24 | 45 (21–62) | 0.001 | |||
| All multiple episodes | |||||||||||||
| >2500 parasites/μl | 447 | 49 | 364 | 0.13 | 447 | 107 | 365 | 0.29 | 54 (31–69) | <0.001 | |||
| >0 parasites/μl | 447 | 57 | 364 | 0.16 | 447 | 117 | 365 | 0.32 | 50 (26–67) | <0.001 | |||
Percentage efficacy was calculated by means of a Cox regression model for the risk of first episodes and a Poisson regression model for multiple episodes. The event rate was calculated by dividing the number of episodes by the person-years at risk. The according-to-protocol analysis was adjusted for the covariates use or nonuse of insecticide-treated net, age, distance from the dispensary, and village; data collection for this analysis began 2 weeks after the last vaccination and ended with the final blood test. The intention-to-treat analysis was unadjusted, and data collection began with the first vaccination and ended with the final blood test.