Table 3. Comparison of changes in anti-Na-GST-1 IgG antibody levels from baseline between US and Brazilian participants vaccinated with Na-GST-1/Alhydrogel or the hepatitis B vaccine.
Results for each study day are presented as the median absolute difference in IgG level (expressed in AU) compared to baseline (Study Day 0).
| 10 μg Na-GST-1 | 30 μg Na-GST-1 | 100 μg Na-GST-1 | HBV Vaccine | p-value* | ||||
|---|---|---|---|---|---|---|---|---|
| Brazil | US | Brazil | US | Brazil | US | |||
| Day 14 | ||||||||
| Sample size (n) | 31 | 12 | 32 | 15 | 32 | 10 | 6 | |
| Median (AU) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0400 |
| Day 28 | ||||||||
| Sample size (n) | 32 | 11 | 32 | 16 | 31 | 11 | 6 | |
| Median (AU) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0261 |
| Day 56 | ||||||||
| Sample size (n) | 32 | 11 | 32 | 16 | 31 | 10 | 5 | |
| Median (AU) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0023 |
| Day 70 | ||||||||
| Sample size (n) | 31 | 11 | 30 | 15 | 31 | 10 | 5 | |
| Median (AU) | 0 | 0 | 15.59 | 6.55 | 15.72 | 15.62 | 0 | < .0001 |
| Day 84 | ||||||||
| Sample size (n) | 31 | 11 | 30 | 16 | 31 | 10 | 5 | |
| Median (AU) | 0 | 0 | 9.29 | 6.38 | 13.87 | 12.54 | 0 | < .0001 |
| Day 112 | ||||||||
| Sample size (n) | 31 | 11 | 29 | 15 | 31 | 9 | 5 | |
| Median (AU) | 0 | 0 | 2.2 | 6 | 4.99 | 7.46 | 0 | 0.0020 |
| Day 126 | ||||||||
| Sample size (n) | 31 | 11 | 29 | 14 | 31 | 9 | 5 | |
| Median (AU) | 4.03 | 10.05 | 60.43 | 16.99 | 123.31 | 86.45 | 0 | < .0001 |
| Day 140 | ||||||||
| Sample size (n) | 30 | 11 | 29 | 14 | 31 | 9 | 4 | |
| Median (AU) | 6.63 | 3.42 | 73.74 | 19.47 | 58.55 | 41.4 | 0 | < .0001 |
*Kruskal-Wallis test comparing all groups.