Safety and Immunogenicity of Radiation-Attenuated PfSPZ Vaccine in Equatoguinean Infants, Children, and Adults.

"Disclosures: Sanaria Inc. manufactured PfSPZ Vaccine, and Protein Potential LLC is affiliated with Sanaria. Sanaria was the sponsor of the clinical trial. L. W. P. C., N. K, E. R. J., Y. A., T. M., P. F. B., B. K. L. S., T. L. R., and S. L. H. are salaried, full-time employees of Sanaria Inc., the developer and sponsor of Sanaria PfSPZ Vaccine. S. R. M., T. C. S., P. R., and E. S. were salaried, full-time employees of Sanaria Inc. at the time the trial was conducted. Thus, all authors associated with Sanaria or Protein Potential have potential conflicts of interest."

"Financial support: This work was supported by a public–private partnership, the EGMVI, made up of the Government of EG Ministries of Mines and Hydrocarbons, and Health and Social Welfare, Marathon EG Production Limited, Noble Energy, Atlantic Methanol Production Company, and EG LNG."

"We express our gratitude to the study participants. We also thank the members of the Safety Monitoring Committee (James Campbell–chair, Brian Greenwood, Mark Riddle, Alberto García-Basteiro, and Feliciano Panades Shumad–safety monitor) for their thoughtful oversight; Almudena Legarda for excellent monitoring; and the entire study team of the Equatorial Guinea Malaria Vaccine Initiative and the teams at Sanaria and Protein Potential for manufacture and shipping of investigational products (PfSPZ Vaccine, PfSPZ Challenge, diluents, and normal saline), regulatory, quality, and clinical site activities, and legal and administrative support. Trial registration: ClinicalTrials.gov (NCT02859350)."