Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis

NCT02080026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-08-10

No results posted yet for this study

Summary

Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, there is desperate need for an effective vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve the level of efficacy necessary to eliminate malaria. It has been shown previously that healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine, medicine that prevents malaria, are fully protected against a subsequent malaria challenge. This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes it a good model to identify what immune responses protect against malaria, to further guide vaccine development. In this study we will use CPS-immunization to induce protection against malaria in healthy subjects and then analyse their immune response to a malaria challenge infection.

Conditions

Interventions

BIOLOGICAL

CPS-immunization

Subjects will receive four 'immunizations' with bites from 15 Plasmodium infected mosquitoes during each immunization, while taking chloroquine prophylaxis.

BIOLOGICAL

Controlled Human Malaria Infection

Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum, NF54 strain.

DRUG

chloroquine

Registered for prophylaxis against infection with Plasmodium falciparum and the treatment of acute infections.

DRUG

atovaquone/proguanil

Registered for use as an antimalarial agent for the treatment of acute infections with Plasmodium falciparum. One tablet contains: atovaquone 250 mg, proguanil(hydrochloride) 100 mg

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER
  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Robert W Sauerwein, Prof. · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Netherlands

Study Locations

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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 NCT02080026 on ClinicalTrials.gov