Study in Blood Stage Malaria Infection After DVI of Cryopreserved P. Falciparum (NF54 Strain) Sporozoites

Summary

This is a single-centre, open-label, Phase Ib study designed to assess if intravenous injection of approximately 3200 P. falciparum (NF54 strain) sporozoites can be safely administered to achieve blood-stage parasitaemia with a kinetics/PCR profile that will allow for the future characterisation of antimalarial blood-stage activity of new chemical entities in a relatively small number of participants during early drug development.

Healthy, malaria-naïve adults, aged 18-55 years, will be enrolled in a maximum of 2 cohorts. Enrolment into the cohorts will proceed sequentially, with two target levels of parasitaemia, i.e., 5000 parasites/mL blood in Cohort 1 and 10000 parasites/mL blood in Cohort 2.

(Based on observed levels of parasitaemia in Cohort 1, the target threshold for treatment in Cohort 2 was maintained at 5,000 p/mL (vs 10,000 p/mL in the protocol)).

The 3-day antimalarial therapy regimen will be further administered and monitored until parasite clearance. Safety and tolerability will be monitored during the whole study duration.

Conditions

• Malaria,Falciparum
• Parasitemia
• Protozoan Infections
• Parasitic Disease

Interventions

DRUG

Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet

artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h

BIOLOGICAL

PfSPZ-DVI Challenge

3200 P. falciparum Sporozoites by direct venous inoculation (DVI)

Sponsors & Collaborators

• SGS Life Sciences, a division of SGS Belgium NV

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• Swiss BioQuant

  collaborator INDUSTRY

• PrimeVigilance Ltd., UK

  collaborator INDUSTRY

• Sanaria Inc.

  collaborator INDUSTRY

• Iqvia Pty Ltd

  collaborator INDUSTRY

• FGK Representative Service B.V., The Netherlands

  collaborator INDUSTRY

• Medicines for Malaria Venture

  lead OTHER

Principal Investigators

• Farouk Chughlay, MD · Medicines for Malaria Venture

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-19

Primary Completion

2020-12-17

Completion

2020-12-17

FDA Drug

Yes

Countries

• Belgium

Study Locations