Table 2. Clinical laboratory adverse events after vaccination with Na-GST-1/Alhydrogel (with or without GLA-AF) or the hepatitis B vaccine in US and Brazilian adults.
Data are number (%) of participants experiencing an event after any vaccination. Results for the different doses of Na-GST-1 and GLA-AF are combined. Participants with more than one occurrence of the same adverse event are recorded only once, at the maximum severity experienced.
| Na-GST-1/Alhydrogel (n = 60) | Na-GST-1/Alhydrogel + GLA-AF (n = 76) | HBV Vaccine (n = 6) | ||||||
|---|---|---|---|---|---|---|---|---|
| Mild | Moderate | Severe | Mild | Moderate | Severe | Mild | Moderate/Severe | |
| N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | |
| Low Hemoglobin Concentration | 10 (17) | – | – | 7 (9) | – | 1 (1) | – | – |
| Reduction in Hemoglobin from Baseline* | 24 (40) | 9 (15) | 1 (2) | 21 (28) | 8 (11) | 4 (5) | 1 (17) | 1 (17) |
| Increased WBC | 6 (10) | – | – | 10 (13) | – | – | 1 (17) | – |
| Decreased WBC | 1 (2) | – | – | 4 (5) | – | – | – | – |
| Decreased ANC | 3 (5) | 1 (2) | – | 1 (1) | 1 (1) | – | – | – |
| Decreased Platelets | – | – | – | – | – | – | – | – |
| Increased ALT | 2 (3) | – | – | 4 (5) | – | – | – | – |
| Increased creatinine | 2 (3) | – | – | 1 (1) | – | – | – | – |
HBV, hepatitis B virus; WBC, white blood cell count; ANC, absolute neutrophil count; ALT, alanine aminotransferase.
*From Study Day 0