CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Pb(PfCS@UIS4)-infected mosquitoes +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03138096
NCT03138096Phase 2Completed
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Safety and Protective Efficacy of Genetically Modified Plasmodium Berghei (Pb(PfCS@UIS4)) Malaria Parasites in Healthy Volunteers

Radboud University Medical Center·interventional·Posted May 3, 2017·Updated Mar 4, 2022

In Brief

A Phase 2 clinical trial evaluating Pb(PfCS@UIS4)-infected mosquitoes and Challenge infection P. falciparum for Malaria,Falciparum and 3 related conditions. Completed, enrolled 24 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria,Falciparum, Plasmodium Falciparum, Plasmodium Berghei, Controlled Human Malaria Infection (CHMI)
CountriesNetherlands
CollaboratorsHavenziekenhuis, Erasmus Medical Center, The PATH Malaria Vaccine Initiative (MVI)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 3, 2017
Enrollment StartMay 29, 2017
Primary CompletionMar 28, 2018
Study CompletionOct 3, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.2 years ago

Interventions

Pb(PfCS@UIS4)-infected mosquitoesbiological

Pb(PfCS@UIS4)-infected mosquitoes

Challenge infection P. falciparumother

Challenge infection with bites of five infected Pf mosquitoes