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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04310085 | Study in Blood Stage Malaria Infection After DVI of Cryopreserved P. Falciparum (NF54 Strain) Sporozoites | PHASE1 | COMPLETED | 16 | — | — | Feb 19, 2020 | Dec 17, 2020 | Sep 5, 2021 | 1 | Belgium |
Based on their start date(time), AEs will be allocated to the phase during which they started (Screening, Challenge, Rescue). Each AE will therefore be reported in only one phase.
Malaria Clinical Score 14 signs/symptoms frequently associated with malaria will be graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3): headache, myalgia (muscle ache), arthralgia (joint ache), fatigue/lethargy, malaise (general discomfort/uneasiness), chills/shivering/rigors, sweating/hot spells, anorexia, nausea, vomiting, abdominal discomfort, fever, tachycardia and hypotension. Malaria clinical score is calculated as the sum of all (14) malaria sign and symptoms scores (maximum score is 42).
For the purpose of this study, 'PCR positivity' is used for the 'protocol-defined PCR positivity'
POSITIVE PARASITAEMIA IS DEFINED AS qPCR OUTCOME \>=250 PARASITES per mL BLOOD.
| Arm | Type | Description |
|---|---|---|
| PfSPZ-DVI challenge and artemether lumefantrine | EXPERIMENTAL | 16 healthy, malaria-naïve males and females, aged 18-55 years, were enrolled in 2 cohorts (8 participants/cohort; a participant may be enrolled in one cohort only). There were two target levels of parasitaemia previously achieved in healthy participants in malaria VIS at other study sites, i.e., 5000 parasites/mL blood in Cohort 1 and 10000 parasites/mL blood in Cohort 2. (Based on observed levels of parasitaemia in Cohort 1, the target threshold for treatment in Cohort 2 was maintained at 5,000 p/mL). qPCR was performed, malaria clinical score assessed twice daily and participants were administered registered antimalarial therapy, i.e., Riamet®, when the following criteria were met: 1. Cohort 1: ≥5000 parasites/mL blood or earlier if a participant has a malaria clinical score \>6 or at Investigator's discretion. 2. Cohort 2: ≥10000 parasites/mL blood or earlier if a participant has a malaria clinical score \>6 or at Investigator's discretion. |
| Name | Type | Description |
|---|---|---|
| Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet | DRUG | artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h |
| PfSPZ-DVI Challenge | BIOLOGICAL | 3200 P. falciparum Sporozoites by direct venous inoculation (DVI) |
Inclusion Criteria: 1. Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study, including administration of registered antima...