Trials / Completed
CompletedNCT04666350
Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays
Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays in Adults With Varying Plasmodium Falciparum Gametocyte Densities
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 42 (actual)
- Sponsor
- PATH · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- —
Summary
The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval.
Detailed description
The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval. The results will determine the type of pivotal trial design for a follow-on Phase 2b trial whose objective is to bridge the standard membrane feeding assay (SMFA) to the direct skin feeding assay (DSFA) and direct membrane feeding assay (DMFA) using a monoclonal antibody intervention, TB31F monoclonal antibody (mAb), which interrupts transmission from human to mosquito. The results from this experimental medicine study will inform whether the preferred "Before-After" trial design in which each human volunteer serves as their own internal control can be utilized for a follow-on Phase 2b trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Direct Skin Feeding Assay (DSFA) | In the direct feeding assay a cup with 60 unfed, sterile insectary-reared Anopheles gambiae mosquitoes will be allowed to feed on a participant's calf or arm for 15 minutes. |
| DRUG | Primaquine | Participants will receive one dose of primaquine 26.3 mg tablet on Day 2 after completion of the direct feeding assay. |
| DRUG | Artemether/Lumefantrine | Participants will receive artemether (80 mg) and lumefantrine (480 mg) combination tablets twice a day for 3 days, starting after completion of the direct feeding assay on Day 2. |
Timeline
- Start date
- 2021-03-09
- Primary completion
- 2021-12-20
- Completion
- 2021-12-20
- First posted
- 2020-12-14
- Last updated
- 2024-04-29
- Results posted
- 2024-04-29
Locations
1 site across 1 country: Kenya
Source: ClinicalTrials.gov record NCT04666350. Inclusion in this directory is not an endorsement.