Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05135273 | Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M Against Malaria in Adults in Mali | PHASE1 | COMPLETED | 80 | — | — | Oct 22, 2021 | Jun 21, 2023 | May 6, 2024 | 1 | Mali |
The analyses included only subjects who received at least one vaccination
| Arm | Type | Description |
|---|---|---|
| 1a (Pilot Group) | EXPERIMENTAL | (n=5) to receive 12.5 µg Pfs230D1-EPA/25 µg Matrix-M on D1, D29, D57 |
| 1b (Pilot Group) | EXPERIMENTAL | (n=5) to receive 20 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 |
| 1c (Pilot Group) | EXPERIMENTAL | (n=5) to receive 40 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 |
| 1d (Pilot Group) | ACTIVE_COMPARATOR | (n=4) to receive rabies vaccine (standard dose) on D1, D29, D57 |
| 2a (Main Group) | EXPERIMENTAL | (n=15) to receive 12.5 µg Pfs230D1-EPA/25 µg Matrix-M on D1, D29, D57 |
| 2b (Main Group) | EXPERIMENTAL | (n=15) to receive 20 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 |
| 2c (Main Group) | EXPERIMENTAL | (n=15) to receive 40 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 |
| 2d (Main Group) | ACTIVE_COMPARATOR | (n=16) to receive rabies vaccine (standard dose) on D1, D29, D57 |
| Name | Type | Description |
|---|---|---|
| Pfs230D1-EPA/Matrix-M Vaccine | BIOLOGICAL | Each single-use vial of Pfs230D1M-EPA contains 160 µg/mL of conjugated Pfs230D1M and 124 µg/mL or 143 µg/mL of conjugated EPA in 4 mM phosphate-buffered saline (PBS), in a volume of 0.5 mL. Each vial of Matrix-M1 contains saponin content of 0.375 mg/mL in PBS, at a pH of 7.2, in a final volume of 0.75 mL. Components will be combined in volumes defined in the protocol at point of use. |
| Verorab Rabies Vaccine | BIOLOGICAL | Verorab Rabies Vaccine is a purified inactivated rabies vaccine (Wistar rabies PM/WI 38 1503-3M strain) prepared on Vero cells. It is supplied as a powder and solvent for suspension for injection in a prefilled syringe. Before reconstitution, the powder is a white and homogeneous pellet. The solvent is a limpid solution. |
INCLUSION CRITERIA: All of the following criteria must be fulfilled for a volunteer to participate in this trial: 1. Age: \> 18 years old and \< 50 years old. 2. Available for the duration of the trial. 3. Known resident or long-term resident (more than 1 year) of Sotuba, Mali or surrounding villa...