Comparison of Three Plasmodium Falciparum Isolates in a Controlled Human Malaria Infection — TIP3  

Malaria Clinical Trial

Official title: Comparison of NF54, NF135 and NF166 Strains of Plasmodium Falciparum in a Controlled Human Malaria Infection (TIP3)

Status Completed

Clinical Trial Summary

An effective vaccine against malaria is urgently needed to combat the scourge of this disease. Before candidate vaccines can be tested in endemic countries, they are first tested in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a candidate vaccine should be tested against multiple strains of malaria, representative of the disease's global distribution. To date, however, only one such strain (NF54) has been broadly used in CHMI's.

The purpose of this study is to compare the course of infections with 2 novel malaria strains to those with NF54 in human volunteers.

Clinical Trial Description

Plasmodium falciparum (Pf) malaria remains responsible for an intolerable burden of morbidity worldwide and an effective vaccine is sorely needed to aid control efforts. Before candidate malaria vaccines can enter full-scale (phase IIb) field trials in endemic areas, they must first be tested under controlled circumstances in (phase IIa) clinical human malaria infection studies. Since Pf isolates display a wide genetic diversity across the globe, phase IIa challenge infections should be conducted with both homologous and heterologous strains.

Since 1998 a highly successful Controlled Human Malaria Infection model at the UMC St Radboud, Nijmegen, The Netherlands, has been employed both to test candidate vaccines and to answer fundamental questions about pathophysiological and immunological mechanisms during early Pf infection in human volunteers. To date largely the NF54 strain of P. falciparum has been used in this Nijmegen model, with which extensive experience has meanwhile been acquired. In order to increase the portfolio of Pf strains available for future phase IIa studies, it is first necessary to document in detail the parasitological, clinical and immunological characteristics of new candidate strains during a controlled human malaria infection. In this study, the strains NF135 and NF166 will be compared in this regard with the well-characterised NF54 strain. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT01627951
• Study type: Interventional
• Source: Radboud University
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Completion date: November 2012