title: Progress with Plasmodium falciparum sporozoite (PfSPZ)-based malaria vaccines.
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.
authors.affiliation: Sanaria Inc., Rockville, MD, United States. Electronic address: trichie@sanaria.com.
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Richie
authors.affiliation: Sanaria Inc., Rockville, MD, United States.
authors.forename: Peter F
authors.initials: PF
authors.lastname: Billingsley
authors.affiliation: Sanaria Inc., Rockville, MD, United States.
authors.forename: B Kim Lee
authors.initials: BK
authors.lastname: Sim
authors.affiliation: Sanaria Inc., Rockville, MD, United States.
authors.forename: Eric R
authors.initials: ER
authors.lastname: James
authors.affiliation: Sanaria Inc., Rockville, MD, United States.
authors.forename: Sumana
authors.initials: S
authors.lastname: Chakravarty
authors.affiliation: Naval Medical Research Center, Silver Spring, MD, United States.
authors.forename: Judith E
authors.initials: JE
authors.lastname: Epstein
authors.affiliation: Center for Malaria Research, Institute for Global Health, University of Maryland School of Medicine, Baltimore, MD, United States.
authors.forename: Kirsten E
authors.initials: KE
authors.lastname: Lyke
authors.affiliation: Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Mordmüller
authors.affiliation: Barcelona Institute for Global Health (ISGlobal), Barcelona, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: Alonso
authors.affiliation: Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD, United States.
authors.forename: Patrick E
authors.initials: PE
authors.lastname: Duffy
authors.affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali.
authors.forename: Ogobara K
authors.initials: OK
authors.lastname: Doumbo
authors.affiliation: Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Sauerwein
authors.affiliation: Swiss Tropical and Public Health Institute, Basel, Switzerland.
authors.forename: Marcel
authors.initials: M
authors.lastname: Tanner
authors.affiliation: Ifakara Health Institute, Bagamoyo, United Republic of Tanzania.
authors.forename: Salim
authors.initials: S
authors.lastname: Abdulla
authors.affiliation: Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kremsner
authors.affiliation: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, United States.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Seder
authors.affiliation: Sanaria Inc., Rockville, MD, United States.
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Hoffman
mesh_terms: D000328:Adult; D000349:Africa; D002986:Clinical Trials as Topic; D015925:Cryopreservation; D060740:Disease Eradication; D005060:Europe; D006801:Humans; D017780:Malaria Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D016778:Malaria, Falciparum / Q000517:prevention & control*; D010963:Plasmodium falciparum / Q000235:genetics / Q000276:immunology*; D034101:Sporozoites / Q000276:immunology*; D064166:Vaccine Potency; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D017780:Malaria Vaccines; D014613:Vaccines, Attenuated
keywords: Malaria vaccine; PfSPZ Challenge; PfSPZ Vaccine; PfSPZ-CVac; Plasmodium falciparum; Sporozoite