Table 2.
Type and number of grade 2 adverse events in the pre-erythrocytic phase: between day of injection (day 0) and day 5
| Adverse event description | CHMI Groups | Total | |||||
|---|---|---|---|---|---|---|---|
| Group 1 2,500 PfSPZ 10 µL × 2 IM |
Group 2 2,500 PfSPZ 50 µL × 2 IM |
Group 3 2,500 PfSPZ 250 µL × 2 IM |
Group 4 3,200 PfSPZ 500 µL × 1 DVI |
Group 5 25,000 PfSPZ 10 µL × 2 IM |
Group 6 75,000 PfSPZ 10 µL × 2 IM |
||
| Abdominal pain | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Atopic dermatitis lesions | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Common cold | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Diarrhoea | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Dysmenorrhoea | 0 | 0 | 0 | 1 | 1 | 1 | 3 |
| Dyspepsia | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Headache | 1 | 0 | 0 | 0 | 1 | 0 | 2 |
| Muscle spasm | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Total | 4 | 1 | 1 | 1 | 2 | 2 | 11 |
PfSPZ Plasmodium falciparum sporozoite, IM intramuscular injection, DVI direct venous inoculation.