Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso

Summary

This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this protocol is to determine the safety and reactogenicity of the PfSPZ Vaccine in malaria-experienced healthy adults. The study duration shall be 34 months and subject participation duration shall be 15-26 months.

Timeline

Start

2016-04-07

Primary completion

2018-12-17

Completion

2018-12-17

Publications

• Potter GE, Callier V, Shrestha B, Joshi S, Dwivedi A, Silva JC, Laurens MB, Follmann DA, Deye GA. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials? Malar J. 2023 Dec 19;22(1):383. doi: 10.1186/s12936-023-04802-0.
• Potter GE, Callier V, Shrestha B, Joshi S, Dwivedi A, Silva JC, Laurens MB, Follmann DA, Deye GA. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials? Res Sq [Preprint]. 2023 Sep 22:rs.3.rs-3370731. doi: 10.21203/rs.3.rs-3370731/v1.

Drugs

Indications