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Vaccine. 2015 Dec 22;33(52):7452-61. doi: 10.1016/j.vaccine.2015.09.096. Epub 2015 Nov 27.

Progress with Plasmodium falciparum sporozoite (PfSPZ)-based malaria vaccines.

Author information

1
Sanaria Inc., Rockville, MD, United States. Electronic address: trichie@sanaria.com.
2
Sanaria Inc., Rockville, MD, United States.
3
Naval Medical Research Center, Silver Spring, MD, United States.
4
Center for Malaria Research, Institute for Global Health, University of Maryland School of Medicine, Baltimore, MD, United States.
5
Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.
6
Barcelona Institute for Global Health (ISGlobal), Barcelona, Spain.
7
Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD, United States.
8
Malaria Research and Training Center, University of Bamako, Bamako, Mali.
9
Radboud University Medical Center, Nijmegen, The Netherlands.
10
Swiss Tropical and Public Health Institute, Basel, Switzerland.
11
Ifakara Health Institute, Bagamoyo, United Republic of Tanzania.
12
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, United States.

Abstract

Sanaria Inc. has developed methods to manufacture, purify and cryopreserve aseptic Plasmodium falciparum (Pf) sporozoites (SPZ), and is using this platform technology to develop an injectable PfSPZ-based vaccine that provides high-grade, durable protection against infection with Pf malaria. Several candidate vaccines are being developed and tested, including PfSPZ Vaccine, in which the PfSPZ are attenuated by irradiation, PfSPZ-CVac, in which fully infectious PfSPZ are attenuated in vivo by concomitant administration of an anti-malarial drug, and PfSPZ-GA1, in which the PfSPZ are attenuated by gene knockout. Forty-three research groups in 15 countries, organized as the International PfSPZ Consortium (I-PfSPZ-C), are collaborating to advance this program by providing intellectual, clinical, and financial support. Fourteen clinical trials of these products have been completed in the USA, Europe and Africa, two are underway and at least 12 more are planned for 2015-2016 in the US (four trials), Germany (2 trials), Tanzania, Kenya, Mali, Burkina Faso, Ghana and Equatorial Guinea. Sanaria anticipates application to license a first generation product as early as late 2017, initially to protect adults, and a year later to protect all persons >6 months of age for at least six months. Improved vaccine candidates will be advanced as needed until the following requirements have been met: long-term protection against natural transmission, excellent safety and tolerability, and operational feasibility for population-wide administration. Here we describe the three most developed whole PfSPZ vaccine candidates, associated clinical trials, initial plans for licensure and deployment, and long-term objectives for a final product suitable for mass administration to achieve regional malaria elimination and eventual global eradication.

KEYWORDS:

Malaria vaccine; PfSPZ Challenge; PfSPZ Vaccine; PfSPZ-CVac; Plasmodium falciparum; Sporozoite

PMID:
26469720
PMCID:
PMC5077156
DOI:
10.1016/j.vaccine.2015.09.096
[Indexed for MEDLINE]
Free PMC Article

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