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Malaria Journal

Open Access

Controlled human malaria infections using aseptic, purified cryopreserved Plasmodium falciparum sporozoites administered by needle and syringe

  • Peter Billingsley1,
  • B Kim Lee Sim1,
  • Else Bijker2,
  • Meta Roestenberg3,
  • Kirsten Lyke4,
  • Matthew Laurens4,
  • Benjamin Mordmueller5,
  • Patricia Gomez6,
  • Seif Shekalaghe7,
  • Susanne Hodgson8,
  • Adrian Hill8,
  • Elizabeth Juma9,
  • Bernhards Ogutu9,
  • Bertrand Lell10,
  • Pedro Alonso11,
  • Salim Abdullah7,
  • Peter Kremsner5,
  • Marcel Tanner12,
  • Robert Sauerwein2 and
  • Stephen Hoffman1
Malaria Journal201413(Suppl 1):P12

Published: 22 September 2014


MalariaInfection RateIntravenous AdministrationPlasmodiumDose Response

Controlled human malaria infection (CHMI) studies, in which healthy volunteers are infected with Plasmodium falciparum (Pf), until recently have been performed primarily by using Pf-infected Anopheles stephensi mosquitoes to bite human subjects. This approach has proven highly successful for studies of drugs and vaccines. However, its use has been limited to the few clinical centers, which have access to Pf-infected mosquitoes. Sanaria Inc. has established a new CHMI methodology whereby aseptic, purified, cryopreserved, infectious sporozoites (SPZ) of Pf are used to infect volunteers when administered by needle and syringe. This product is known as PfSPZ Challenge. Here we summarize the results of seven clinical trials in the Netherlands, UK, Tanzania, USA, Germany, Spain, and Kenya including 178 subjects. Four of the trials were done in countries where CHMI had never been done before. These trials assessed intradermal, intramuscular and intravenous administration of varying doses of PfSPZ Challenge. The three primary goals of 100% infection rates, a prepatent period comparable to the bite of five Pf-infected mosquitoes (11 to 11.5 days) and a dose response have been met by intravenous and intramuscular administration. PfSPZ Challenge opens up the potential for CHMI to be done in any research facility set up for clinical malaria studies (see presentation by Sheehy et al.), including sites to which transport of A. stephensi is difficult or impossible (i.e. any site in Africa). The results of all the studies will be presented.

Authors’ Affiliations

Sanaria Inc., Rockville, USA
Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
University of Leiden, Leiden, The Netherlands
Center for Vaccine Development, University of Maryland, Baltimore, USA
Universität Tübingen, Tübingen, Germany
Centre de Recerca en Salut Internacional de Barcelona Hospital, Barcelona, Spain
Ifakara Health Institute, Bagamoyo, Tanzania
University of Oxford, Oxford, UK
Kenya Institute for Medical Research, Nairobi, Kenya
CERMEL, Lambaréné, Gabon
Barcelona Centre for International Health Research, Barcelona, Spain
Swiss Tropical and Public Health Institute, Basel, Switzerland


© Billingsley et al; licensee BioMed Central Ltd. 2014

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.


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