NCT03138096

Safety and Protective Efficacy of Pb(PfCS@UIS4)

Safety and Protective Efficacy of Genetically Modified Plasmodium Berghei (Pb(PfCS@UIS4)) Malaria Parasites in Healthy Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-03-28
• Completion: 2018-10-03
• First posted: 2017-05-03
• Last updated: 2022-03-04
• Results posted: 2021-12-15

Locations

2 sites across 1 country: Netherlands