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Controlled Human Malaria Infection Model for Evaluation of Transmission-Blocking Interventions - Study 1

NCT02836002 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-03-23

No results posted yet for this study

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

Interventions

DRUG

Sulfadoxine-pyrimethamine (low dose)

\- subcurative regimen (500mg/25mg)

DRUG

Piperaquine (low dose)

\- subcurative regimen (480 mg)

DRUG

Sulfadoxine-pyrimethamine (high dose)

\- curative regimen (1000mg/50mg)

DRUG

Piperaquine (high dose)

\- curative regimen (960 mg)

BIOLOGICAL

malaria challenge infection, P. falciparum 3D7

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

DRUG

Atovaquone-proguanil

\- curative regimen: 1000/400 mg, for 3 days

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
2016-06-30
Primary Completion
2017-06-29
Completion
2017-06-29

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT02836002 on ClinicalTrials.gov