Safety and Protective Efficacy of Pb(PfCS@UIS4)

Phase 1/2 Completed 24 enrolled Radboud University Medical Center Erasmus Medical Center · collab Havenziekenhuis · collab The PATH Malaria Vaccine Initiative (MVI) · collab

Non-randomizedParallel-groupOpen-labelPrevention

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).

Timeline

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

Outcome

Missed primary endpoint

paper Although protective efficacy evaluated by CHMI showed no sterile protection at the tested dose PMID 32434846 ↗

Publications

Results Reuling IJ, Mendes AM, de Jong GM, Fabra-Garcia A, Nunes-Cabaco H, van Gemert GJ, Graumans W, Coffeng LE, de Vlas SJ, Yang ASP, Lee C, Wu Y, Birkett AJ, Ockenhouse CF, Koelewijn R, van Hellemond JJ, van Genderen PJJ, Sauerwein RW, Prudencio M. An open-label phase 1/2a trial of a genetically modified rodent malaria parasite for immunization against Plasmodium falciparum malaria. Sci Transl Med. 2020 May 20;12(544):eaay2578. doi: 10.1126/scitranslmed.aay2578.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pb(PfCS@UIS4)	Unknown	5 unknown	Other
Subject	Pb(PfCS@UIS4)	Unknown	25 unknown	Other
Subject	Pb(PfCS@UIS4)	Unknown	75 unknown	Other