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Controlled Human Malaria Infection Transmission Model - Phase A

NCT04280692 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-05-23

No results posted yet for this study

Summary

This is to develop a model to test the efficacy of vaccines and/or drugs designed to block transmission of malaria to mosquitoes and to identify the targets of transmission-blocking immunity to malaria.

Conditions

  • Malaria,Falciparum

Interventions

BIOLOGICAL

PfSPZ Challenge

Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites

DRUG

Sulfadoxine-Pyrimethamine

Sub-curative 500mg/25mg single dose regimen

DRUG

Piperaquine

Sub-curative 480mg single dose regimen

DRUG

Artemether lumefantrine

Three day curative regimen 20mg/120mg

DRUG

Primaquine

Single low dose regimen 0.25 mg base/kg

Sponsors & Collaborators

  • KEMRI-Wellcome Trust Collaborative Research Program

    collaborator OTHER

  • Sanaria Inc.

    collaborator INDUSTRY

  • Kenya Medical Research Institute

    collaborator OTHER

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2025-12-31
Completion
2026-08-31

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04280692 on ClinicalTrials.gov