Table 2.
The results of Phase III one-month trial of daily oral M. vaccae as an immune adjunct to TB therapy.
| Arm | N | Gender F/M |
Age | Height (cm) | Diagnosis* | Sputum conversion (%) | Sputum score |
Weight (kg) |
BMI (kg/cm2) |
Protein (g/L) |
Hb (g/dL) |
Bilirubin (µM/L) |
ESR (mm/h) |
WBC (x109L) |
Lymphocyte (%) |
ALT (mM/h*L) |
AST (mM/h*L) |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Before | After | Before | After | Before | After | Before | After | Before | After | Before | After | Before | After | Before | After | Before | After | Before | After | Before | After | |||||||
| V7 | 100 | 26/74 | 39.3 ±11 |
172.1 ±6.6 |
DS = 45 MDR = 45 XDR = 1 TB/HIV = 9 |
DS = 86.7 MDR = 55.6 XDR = 0 TB/HIV = 44.4 |
1.12 ±0.41 |
0.33 ±0.47 |
64.2 ±8.3 |
66.6 ±8.2 |
21.4 ±2.1 |
22.2 ±2.1 |
73.8 ±5.1 |
74.6 ±5.6 |
132 ±17.8 |
136.9 ±14.7 |
11.4 ±2.4 |
13.7 ±3.4 |
18.2 ±12 |
12.4 ±9 |
8.95 ±3.7 |
7.45 ±2.3 |
26.4 ±7.0 |
26.8 ±5.6 |
0.34 ±0.15 |
0.33 ±0.21 |
0.16 ±0.09 |
0.17 ±0.07 |
| P < 0.0001 | P < 0.0001 | P<0.0001 | P=0.043 | P=0.001 | P<0.0001 | P<0.0001 | P<0.0001 | P=0.96 | P=0.65 | P=0.41 | ||||||||||||||||||
| Placebo | 52 | 7/45 | 39.6 ±9.9 |
172.9 ±7.0 |
DS = 22 MDR = 20 XDR = 1 TB/HIV = 9 |
DS = 27.2 MDR = 15 XDR = 0 TB/HIV = 33.3 |
1.23 ±0.55 |
1.04 ±0.77 |
61.5 ±10.7 |
61.8 ±10.5 |
20.5 ±3 |
20.7 ±3 |
74.6 ±6.1 |
74.6 ±5.6 |
128.4 ±15.8 |
126.7 ±17.2 |
11.03 ±3.1 |
13.9 ±4.01 |
16.9 ±11.6 |
17.3 ±13.3 |
8.1 ±2.4 |
7.9 ±2.8 |
27.8 ±5.7 |
29.3 ±5.3 |
0.39 ±0.46 |
0.54 ±0.61 |
0.13 ±0.05 |
0.17 ±0.07 |
| P=0.07 | P = 0.18 | P = 0.1 | P=0.93 | P=0.44 | P=0.0015 | P=0.77 | P=0.56 | P=0.85 | P=0.04 | P=0.005 | ||||||||||||||||||
| This row compares post-treatment data between groups, V7 and placebo; P values are from unpaired t-test; Δ is difference between means and within parentheses are ranges of values at 95%CI confidence intervals separated by coma |
P < 0.0001 Δ = 0.71 95%CI(0.51,0.91) |
P = 0.0025 Δ = 4.8 95%CI(1.7,7.8) |
P = 0.0003 Δ = 1.5 95%CI(0.7,2.4) |
P=0.99 Δ=0.008 95%CI(-2.6,2.6) |
P=0.0002 Δ=10.2 95%CI(4.9,15.5) |
P=0.35 Δ=0.8 95%CI(0.9,2.4) |
P=0.008 Δ=4.9 95%CI(1.3,8.5) |
P=0.33 Δ=0.45 95%CI(-1.3,0.4) |
P=0.01 Δ=2.5 95%CI(0.6,4.6) |
P=0.002 Δ=0.21 95%CI(0.1,0.35) |
P=0.47 Δ=0.01 95%CI(-0.02,0.05) |
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*In TB/HIV category, among those in V7 arm, 4 had DS-TB and 5 MDR-TB; while in placebo all patients had DS-TB. Most of numeric data values are expressed as means ± standard deviations (SD). Continuous data were analyzed by pairwise Student's t-test. Lower row contains data from comparison analysis (inter-group difference) between V7 and placebo groups by unpaired t-test with Δ-difference from respective means and ranges between lower and upper values at 95% confidence intervals (CI).