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Safety and Protective Efficacy of Pb(PfCS@UIS4)

NCT03138096 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-03-04

Study results available
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Summary

In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that immunization of humans with P. berghei will induce a cross-species immune response without the risk of a breakthrough infection. To further increase the potential for protective efficacy, the P. falciparum circumsporozoite (CS)- protein gene has been integrated in the P. berghei parasite, generating a genetically modified P. berghei parasite, abbreviated as Pb(PfCS@UIS4).

Conditions

  • Malaria,Falciparum
  • Plasmodium Falciparum
  • Plasmodium Berghei
  • Controlled Human Malaria Infection (CHMI)

Interventions

BIOLOGICAL

Pb(PfCS@UIS4)-infected mosquitoes

Pb(PfCS@UIS4)-infected mosquitoes

OTHER

Challenge infection P. falciparum

Challenge infection with bites of five infected Pf mosquitoes

Sponsors & Collaborators

  • Havenziekenhuis

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Robert Sauerwein, MD PhD · Radboud University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-29
Primary Completion
2018-03-28
Completion
2018-10-03

Countries

  • Netherlands

Study Locations

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Entities

Companies

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 NCT03138096 on ClinicalTrials.gov