Volume 13 Supplement 1

Challenges in malaria research: Core science and innovation

Open Access

Progress with PfSPZ Vaccine, a radiation attenuated Plasmodium falciparum sporozoite vaccine

  • Peter Billingsley1,
  • B Kim Lee Sim1,
  • Eric James1,
  • Thomas Richie1,
  • Seif Shekalaghe2,
  • Sara Healy3,
  • Mahamadou Sissoko4,
  • Benjamin Mordmueller5,
  • Julie Ledgerwood6,
  • Barney Graham6,
  • Patrick Duffy3,
  • Robert Seder6,
  • Kirsten Lyke7,
  • Judith Epstein8,
  • Pedro Alonso9,
  • Salim Abdullah2,
  • Ogobara Duombo4,
  • Peter Kremsner5,
  • Marcel Tanner10 and
  • Stephen Hoffman1
Malaria Journal201413(Suppl 1):O34

https://doi.org/10.1186/1475-2875-13-S1-O34

Published: 22 September 2014

Sanaria® PfSPZ Vaccine is composed of aseptic, purified, cryopreserved, attenuated (non-replicating), metabolically active Plasmodium falciparum (Pf ) sporozoites (SPZ) produced in compliance with good manufacturing practices (GMPs) that meet all regulatory standards. This vaccine provided full protection against Pf infection in 100% (6/6) volunteers, who received five doses of 1.35 × 105 PfSPZ administered intravenously in a study at the Vaccine Research Center (VRC), NIAID, NIH [1]. Based on these data, the PfSPZ Vaccine Clinical Consortium composed of investigators from USA, Africa, and Europe has developed a four stage clinical development plan (CDP) that maps out a 4-5 year timeline to licensure and a large scale demonstration project to eliminate malaria from an island population in Africa. In 2014, six different clinical trials of PfSPZ Vaccine at seven clinical sites in the United States (Bethesda, Baltimore, Silver Spring), Mali, Tanzania, Equatorial Guinea, and Germany will be underway. These six clinical trials, which include >450 subjects, comprise Stage 1 of the four stage PfSPZ Vaccine CDP. They are designed to 1) assess the reproducibility of the data generated in the VRC study and 2) assess and optimize durability of protection, protection against heterologous strains of Pf, reduction in numbers of doses, immune assays that predict protection, implementation of immunization, and alternative route of administration. We will provide an update of these stage 1 clinical trials and plans for stage 2 studies that will address questions required for progressing to pivotal phase 3 clinical trials in stage 3, and to demonstration projects for focal elimination in small populations.

Authors’ Affiliations

(1)
Sanaria Inc.
(2)
Ifakara Health Institute
(3)
Laboratory for Malaria Immunology and Vaccinology, NIAID-NIH
(4)
Malaria Research and Training Cente
(5)
Institut für Tropenmedizin
(6)
Vaccine Research Center, NIAID-NIH
(7)
Center for Vaccine Development, University of Maryland
(8)
Navy Medical Research Center
(9)
Barcelona Centre for International Health Research
(10)
Swiss Tropical and Public Health Institute

References

  1. Seder RA, Chang LJ, Enama ME, Zephir KL, Sarwar UN, Gordon IJ, Holman LA, James ER, Billingsley PF, Gunasekera A: Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine. Science. 2013, 341: 1359-1365. 10.1126/science.1241800.View ArticlePubMedGoogle Scholar

Copyright

© 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 (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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