Table 2.
Overview of Adverse Events and Other Indicators and Contributors of Reactogenicity in the Chemoprophylaxis Vaccination With Sporozoites Phase Study Population
| CVac Phase | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CVac #1 | CVac #2 | CVac #3 | ||||||||||
| Pilot PQ/ CQ, n = 6 | PQ/CQ, n = 13a | CQ, n = 5 | Drug Control, n = 6 | Pilot PQ/CQ, n = 5 | PQ/CQ, n = 12 | CQ, n = 4 | Drug Control, n = 6 | Pilot PQ/ CQ, n = 5 | PQ/CQ, n = 12 | CQ, n = 4b | Drug Control, n = 6 | |
| Any solicited AE | 5 (83) | 13 (100) | 4 (80) | 6 (100) | 4 (80) | 12 (100) | 3 (75) | 6 (100) | 2 (40) | 11 (92) | 2 (50) | 6 (100) |
| Any SAE | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Any unsolicited AE | 6 (100) | 7 (54) | 1 (20) | 5 (83) | 0 (0) | 5 (42) | 2 (50) | 3 (50) | 3 (60) | 2 (17) | 2 (50) | 3 (50) |
| Any AE related to: | ||||||||||||
| Chloroquine | 3 (50) | 11 (85) | 3 (60) | 4 (67) | 1 (20) | 4 (33) | 0 (0) | 3 (50) | 1 (20) | 2 (17) | 0 (0) | 2 (33) |
| Primaquine/placeboc | 2 (33) | 2 (17) | 2 (40) | 1 (17) | 1 (20) | 2 (17) | 1 (25) | 1 (17) | 1 (20) | 3 (25) | 1 (25) | 0 (0) |
| Local mosquito bites | 5 (83) | 12 (100) | 4 (80) | 5 (83) | 4 (80) | 11 (92) | 2 (50) | 6 (100) | 3 (60) | 11 (92) | 3 (75) | 4 (67) |
| Systemic mosquito bites | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (8) | 0 (0) | 1 (17) |
| Malariad | 2 (33) | 3 (25) | 0 (0) | 1 (17) | 1 (20) | 4 (33) | 0 (0) | 2 (33) | 1 (20) | 3 (25) | 0 (0) | 0 (0) |
| Combination | 4 (67) | 2 (17) | 0 (0) | 0 (0) | 2 (40) | 2 (17) | 0 (0) | 0 (0) | 2 (40) | 6 (50) | 0 (0) | 0 (0) |
| Any lab abnormalities | 3 (50) | 5 (38) | 0 (0) | 1 (17) | 3 (60) | 4 (33) | 0 (0) | 1 (17) | 1 (20) | 7 (58) | 0 (0) | 0 (0) |
| Any related AE by grading: | ||||||||||||
| Grade 1, mild | 5 (83) | 13 (100) | 4 (80) | 6 (100) | 4 (80) | 10 (83) | 2 (50) | 5 (83) | 3 (60) | 10 (83) | 3 (75) | 3 (50) |
| Grade 2, moderate | 3 (50) | 4 (31) | 2 (40) | 4 (67) | 1 (20) | 5 (42) | 0 (0) | 3 (50) | 1 (20) | 5 (42) | 0 (0) | 3 (50) |
| Grade 3, severe | 0 (0) | 1 (8) | 0 (0) | 0 (0) | 1 (20) | 1 (8) | 0 (0) | 0 (0) | 0 (0) | 1 (8) | 0 (0) | 0 (0) |
| Peak parasite density during CVac by qRT-PCR, parasites/mL | ||||||||||||
| Any positive qPCR | 6 (100) | 8 (67) | 5 (100) | 0 (0) | 4 (80) | 9 (75) | 1 (25) | 0 (0) | 3 (60) | 5 (42) | 0 (0) | 0 (0) |
| Detectable to <102 | 1 (17) | 4 (33) | 0 (0) | 0 (0) | 0 (0) | 4 (33) | 0 (0) | 0 (0) | 2 (40) | 3 (25) | 0 (0) | 0 (0) |
| ≥102 to <103 | 0 (0) | 2 (17) | 1 (20) | 0 (0) | 4 (80) | 4 (33) | 1 (25) | 0 (0) | 1 (20) | 2 (17) | 0 (0) | 0 (0) |
| ≥103 to <104 | 4 (67) | 2 (17) | 4 (80) | 0 (0) | 0 (0) | 1 (8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| ≥104 | 1 (17) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Data are number of unique subjects (%), unless stated otherwise.
Abbreviations: AE, adverse event; CQ, chloroquine; CVac, chemoprophylaxis vaccination with sporozoites; PQ, primaquine; qPCR, quantitative polymerase chain reaction; qRT-PCR, quantitative reverse transcription polymerase chain reaction; SAE, severe adverse event; SPZ, sporozoites.
aThe safety population for PQ/CQ arm for the first CVac was 13 for the CQ dose evaluation only, as a subject was withdrawn from the study prior to any further study interventions.
bThe safety population for the CQ arm for CVac #3 was 4, but only 3 subjects were evaluable for parasite density, as a subject was withdrawn secondary to pregnancy on the day of PQ/placebo dosing (Day 1 post–SPZ exposure) and treated.
cPQ-receiving arms: pilot PQ/CQ, PQ/CQ, and drug controls; placebo-receiving arm: CQ.
dSPZ-receiving arms: pilot PQ/CQ, PQ/CQ, and CQ; non–SPZ receiving arm: drug controls.