Table 3.
Impact on CD4+ T-cell Percentages and/or CD4+ T-cell Counts Postimmunization With Monovalent Measles Vaccine or MMRII in HIV-Infected vs HIV-Uninfected Children
| Study week | Changes in CD4+ percentage and/or count | Total | Treatment group |
|||||||||
|
2DNEG |
2DPOS |
1DNEG |
1DPOS |
P valuea | ||||||||
|
n = 65 |
n = 7 |
n = 30 |
n = 8 |
|||||||||
| Number | % | Number | % | Number | % | Number | % | |||||
| Week 6 vs week 0 | Number vaccinated | n = 65 | n = 7 | n = 0 | n = 0 | |||||||
| Total number of subjects with data | n = 64 | n = 7 | n = 28 | n = 8 | ||||||||
| CD4+ toxicity category | ||||||||||||
| No toxicity | 19 | 29.7 | 2 | 28.6 | 11 | 39.3 | 1 | 12.5 | .3020 | |||
| Grade[1]b | 42 | 65.6 | 4 | 57.1 | 16 | 57.1 | 6 | 75.0 | ||||
| Grade[2]b | 3 | 4.7 | 1 | 14.3 | 0 | 0 | 1 | 12.5 | ||||
| Grade[3]b | 0 | 0 | 0 | 0 | 1 | 3.6 | 0 | 0 | ||||
| CD4+ count <750/mm3 Week 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| Week 6 | 0 | 0 | 1 | 14.3 | 0 | 0 | 0 | 0 | ||||
| Mean proportional | ||||||||||||
| ▵CD4+ count (±SD)c | 0.01 (0.40) | 64 | 0.01 (.43) | 7 | 0.08 (0.39) | 28 | –0.01 (0.38) | 8 | 0.03 (0.16) | .9726 | ||
| ▵CD4+ % (±SD)c | 0.00 (0.14) | –0.03 (0.12) | 0.08 (0.14) | 0.05 (0.17) | –0.02 (0.16) | .0785 | ||||||
| Week 32 vs week 26 | Number vaccinated | n = 61 | n = 7 | n = 27 | n = 8 | |||||||
| Total number of subjects with data | n = 55 | n = 7 | n = 24 | n = 8 | ||||||||
| CD4+ toxicity category | ||||||||||||
| No Toxicity | 18 | 32.7 | 2 | 28.6 | 7 | 29.2 | 4 | 50 | .8574 | |||
| Grade[1]b | 36 | 65.5 | 5 | 71.4 | 17 | 70.8 | 4 | 50 | ||||
| Grade[2]b | 1 | 1.8 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| Grade[3]b | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| CD4+ count <750/mm3 | ||||||||||||
| Week 26 | 0 | 0 | 0 | 0 | ||||||||
| Week 32 | 0 | 0 | 0 | 0 | ||||||||
| Mean proportional | ||||||||||||
| ▵CD4+ count (±SD)c | –0.04 (0.29) | 55 | –0.02 (0.27) | 7 | –0.10 (0.22) | 24 | –0.13 (0.27) | 8 | 0.09 (0.47) | .1710 | ||
| ▵CD4+ % (±STD)c | 0.00 (0.18) | –0.02 (0.14) | –0.03 (0.13) | 0.03 (0.23) | 0.13 (0.27) | .4725 | ||||||
NOTE. aMonte Carlo–estimated P values were calculated using the Kruskall-Wallis test.
CD4+ toxicity category: grade[1] CD4+% proportional change <10% and CD4+ count proportional change <20%; grade[2] CD4+% proportional change ≥10% but <40% and CD4+ count proportional change ≥20% but <50%; grade[3] CD4+% proportional change ≥40% and CD4+ count proportional change ≥50%.
{[CD4+ post-CD4+pre]/[CD4+pre]} × 100 = proportional change, where “CD4+” refers to either the absolute count or the percentage of total lymphocytes.
P values for subgroups were calculated only if the overall P value was <.05 using the Wilcoxon signed rank test.