Table 4.
Laboratory abnormalities
| Laboratory parameter* | Grade abnormality | Pilot N (%) | PfSPZ Vaccine N (%) | Normal saline N (%) | |||
|---|---|---|---|---|---|---|---|
| Decreased hemoglobin | 1 | 0 | (0%) | 0 | (0%) | 1 | (10%) |
| Decreased platelets | 1 | 0 | (0%) | 4 | (20%) | 0 | (0%) |
| Increased WBC count | 1 | 0 | (0%) | 5 | (25%) | 2 | (20%) |
| 2 | – | – | 1 | (5%) | – | – | |
| Decreased WBC count | 1 | 1 | (33%) | 5 | (25%) | 5 | (50% |
| Decreased neutrophils | 1 | 1 | (33%) | 17 | (85%) | 8 | (80%) |
| 2 | – | – | 1 | (5%) | 2 | (20%) | |
| Decreased lymphocytes | 1 | 1 | (33%) | 0 | (0%) | 1 | (10%) |
| Increased eosinophils | 1 | 0 | (0%) | 14 | (70%) | 10 | (100%) |
| 2 | – | – | 11 | (55%) | 3 | (30%) | |
| 3 | – | – | 1 | (5%) | – | – | |
| Elevated ALT | 1 | 1 | (33%) | 8 | (40%) | 4 | (40%) |
| Elevated AST | 1 | 0 | (0%) | 6 | (30%) | 3 | (30%) |
| 2 | – | – | 2 | (10%) | – | – | |
| Elevated total bilirubin | 1 | 0 | (0%) | 0 | (0%) | 0 | (0%) |
| Elevated creatinine | 1 | 1 | (33%) | 0 | (0%) | 2 | (20%) |
| Hypoglycemia | 1 | 0 | (0%) | 2 | (10%) | 0 | (0%) |
| Hyperglycemia | 1 | 1 | (33%) | 2 | (10%) | 1 | (10%) |
| 2 | 1 | (33%) | – | – | 1 | (10%) | |
ALT = alanine aminotransferase; AST = aspartate aminotransferase; N = number of volunteers experiencing the abnormality; PfSPZ = Plasmodium falciparum sporozoites; WBC = white blood cell; % = proportion of the number of volunteers in the group experiencing the abnormality. Number (percent) of volunteers experiencing laboratory abnormalities after vaccination (excluding abnormalities identified at screening or prior to the first vaccination).
*
Abnormal Laboratory Values are defined as grade 1 or higher per the protocol defined toxicity ranges.