Autor/a:
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Richie, Thomas L.; Billingsley, Peter F.; Sim, B. Kim Lee; James, Eric R.; Chakravarty, Sumana; Epstein, Judith E.; Lyke, Kirsten E.; Mordmuller, Benjamin; Alonso, Pedro; Duffy, Patrick E.; Doumbo, Ogobara; Sauerwein, Robert W.; Tanner, Marcel; Abdulla, Salim; Kremsner, Peter G.; Seder, Robert A.; Hoffman, Stephen L.
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Abstract:
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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. |