Table 7:
Relationship between ELISPOT Measures of immunosuppression and any viral Infection
| Mechanistic Assays | All Subjects (N=60)* n (%) |
Any Viral Infection (N=52) n (%) |
No Viral Infection (N=8) n (%) |
P-value |
|---|---|---|---|---|
| High immunosuppression per ELISPOT (at least one positive** sample) | ||||
| Yes | 43(71.7) | 41(78.8) | 2(25.0) | 0.003 |
| No | 16(26.7) | 10(19.2) | 6(75.0) | |
| Number of High immunosuppression samples** per Subject | ||||
| 0 | 16(26.7) | 10(19.2) | 6(75.0) | 0.055 |
| 1 | 9(15.0) | 9(17.3) | 0 | |
| 2 | 7(11.7) | 6(11.5) | 1(12.5) | |
| 3 | 7(11.7) | 7(13.5) | 0 | |
| 4 | 11(18.3) | 11(21.2) | 0 | |
| 5 | 5( 8.3) | 5( 9.6) | 0 | |
| 6 | 3( 5.0) | 2( 3.8) | 1(12.5) | |
| 10 | 1( 1.7) | 1( 1.9) | 0 | |
One subject met the composite endpoint without having any viral specimens obtained.
Samples were considered positive for high immunosuppression if the response to positive control (phytohemagglutinin, PHA) was less than 100 spots and cell viability was > 50%.