Table 3.

Triplex postvaccination responses

pp65IE1-exon4IE2-exon5No response
DL1 (N = 8) 
DL2 (N = 8) 
DL3 (N = 8) 
All (N = 24) 20 
P value <.00001 .39 .59 .0002 
pp65IE1-exon4IE2-exon5No response
DL1 (N = 8) 
DL2 (N = 8) 
DL3 (N = 8) 
All (N = 24) 20 
P value <.00001 .39 .59 .0002 

Numbers in the first 3 columns represent Triplex responders, defined as subjects who showed a persistently higher than baseline concentration of pp65-, IE1-exon4, or IE2-exon5-specific CD137+ CD8+ or CD4+ T cells through day 360. “No response” column indicates number of subjects who did not respond to any of the 3 CMV proteins expressed by Triplex vaccine. The first 3 rows show data for each of the DL cohorts. The “All” row combines the data for the three DL. In detail, the chance that an individual is counted as a responder under the null-effect hypothesis is 1 in 9. A subject was classified as a responder if either CD8+ or CD4+ measurements were all higher than baseline, yielding a null-hypothesis probability of 0.21 (independent chances being conservative for our purpose). The first 3 P values are the probability of counts as high as or higher than observed, assuming 24 independent subjects with the null probability. The last P value is the analogous probability that as many or fewer subjects failed to respond to any of the 3 libraries, taking the null hypothesis probability (of failing 6 assessments) to be 0.493 for each subject.

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