Table 1.
Characteristics of the Participants at Baseline in the Efficacy Trial (Part B).*
| Characteristic | L9LS, 150 mg (N = 75) |
L9LS, 300 mg (N = 75) |
Placebo (N = 75) |
|---|---|---|---|
| Median age (range) — yr | 8 (6–10) | 8 (6–10) | 7 (6–10) |
| Sex — no. (%) | |||
| Female | 31 (41) | 33 (44) | 36 (48) |
| Male | 44 (59) | 42 (56) | 39 (52) |
| Median weight (range) — kg | 24 (16–30) | 22 (16–30) | 23 (15–30) |
| Site — no. (%) | |||
| Kalifabougou | 56 (75) | 49 (65) | 52 (69) |
| Torodo | 19 (25) | 26 (35) | 23 (31) |
| Any plasmodium species detected on blood-smear examination at enrollment — no. (%) | 14 (19) | 13 (17) | 12 (16) |
| Plasmodium falciparum | 12 (16) | 13 (17) | 12 (16) |
| P. malariae | 2 (3) | 0 | 0 |
| P. ovale | 0 | 0 | 0 |
| Median interval between administration of artemether–lumefantrine and L9LS or placebo (range) — days | 7 (7–12) | 7 (6–10) | 7 (7–12) |
| Hemoglobin genotype — no. (%) | |||
| Hemoglobin AA | 57 (76) | 62 (83) | 64 (85) |
| Hemoglobin AS | 11 (15) | 7 (9) | 6 (8) |
| Hemoglobin AC | 6 (8) | 6 (8) | 5 (7) |
| Hemoglobin CC | 1 (1) | 0 | 0 |
| Hemoglobin SC | 0 | 0 | 0 |
*
For pediatric participants, the trial was conducted in two parts. Part B was a double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of the monoclonal antibody L9LS.