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controlled phase 1 trial

Not Open Access | Safety and efficacy of a three-dose regimen of Plasmodium falciparum sporozoite vaccine in adults during an intense malaria transmission season in Mali: a randomised, controlled phase 1 trial

November 25, 2021 - 12:35 -- NOT Open Access
Author(s): 
Sissoko MS, Healy SA, Duffy PE, et al.
Reference: 
Lancet Infect Dis. 2021 Nov 18:S1473-3099(21)00332-7

WHO recently approved a partially effective vaccine that reduces clinical malaria in children, but increased vaccine activity is required to pursue malaria elimination. A phase 1 clinical trial was done in Mali, west Africa, to assess the safety, immunogenicity, and protective efficacy of a three-dose regimen of Plasmodium falciparum sporozoite (PfSPZ) Vaccine (a metabolically active, non-replicating, whole malaria sporozoite vaccine) against homologous controlled human malaria infection (CHMI) and natural P falciparum infection.

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