Table 3.
Adverse Events Following Controlled Human Malaria Infection in the 2 Exposure Groups
| Adverse Event | Sero-high Group (n = 9) | Sero-low Group (n = 10) |
|---|---|---|
| Participants with any AE (including laboratory abnormalities) | 5 (55.6) | 9 (90.0) |
| Participants with grade 2 or higher AEs | 2 (22.2) | 8 (80.0) |
| Total grade 1 and 2 AEs | 12 | 61 |
| Headache | 3 (25.0) | 12 (19.7) |
| Fever | 0 | 5 (8.2) |
| Chills | 1 (8.3) | 4 (6.6) |
| Fatigue/malaise | 1 (8.3) | 8 (13.1) |
| Myalgia | 0 | 4 (6.6) |
| Arthralgia | 2 (16.7) | 1 (1.6) |
| Anorexia | 0 | 5 (8.2) |
| Nausea | 0 | 2 (3.3) |
| Vomiting | 0 | 1 (1.6) |
| Abdominal pain | 0 | 2 (3.3) |
| Dizziness | 0 | 3 (4.9) |
| Diarrhea | 0 | 1 (1.6) |
| Rib cage pain | 0 | 1 (1.6) |
| Low platelet count | 1 (8.3) | 2 (3.3) |
| Low lymphocyte count | 1 (8.3) | 5 (8.2) |
| Low absolute neutrophil count | 1 (8.3) | 0 |
| Elevated total bilirubin | 0 | 2 (3.3) |
| Elevated lactate dehydrogenase | 0 | 1 (1.6) |
| Elevated ASTa | 0 | 1 (1.6) |
| Elevated γ-glutamyl transferase | 1 (8.3) | 0 |
| Elevated sodium levels | 1 (8.3) | 1 (1.6) |
| Total grade 3 adverse events | 0 | 9 |
| Headache | 0 | 2 (22.2) |
| Chills | 0 | 2 (22.2) |
| Fatigue/malaise | 0 | 2 (22.2) |
| Low lymphocyte count | 0 | 3 (33.3) |
Data are presented as No. (%).
Abbreviations: AE, adverse event; AST, aspartate aminotransferase.
aNo clinically significant elevations in alanine aminotransferase were observed.