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Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2

NCT03454048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-07-07

Study results available
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Summary

This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf) gametocyte carriers for Anopheles mosquitoes.

Conditions

  • Malaria,Falciparum
  • Gametocytes
  • Controlled Human Malaria Infection
  • Transmission

Interventions

DRUG

Piperaquine (low dose)

subcurative regimen (480 mg)

DRUG

Piperaquine (high dose)

Curative regimen (960mg)

DRUG

Sulfadoxine pyrimethamine

Curative regimen (1000mg/50mg)

DRUG

Atovaquone Proguanil

Curative regimen (1000/400 mg, for 3 days)

OTHER

malaria challenge infection, P. falciparum 3D7

malaria challenge infection by P. falciparum 3D7-infected mosquito bites

OTHER

Blood stage malaria challenge infection, P. falciparum 3D7

P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection.

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • QIMR Berghofer Medical Research Institute

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2018-11-01
Completion
2018-11-20

Countries

  • Netherlands

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 NCT03454048 on ClinicalTrials.gov