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

Plasmodium Falciparum Infection Clinical Trial

Official title:
Dose Escalation Study of Sanaria's Irradiated Sporozoite Vaccine (PFSPZ Vaccine), Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of PfSPZ Vaccine in Malaria-Experienced Adults in Burkina Faso

Clinical Trial 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.

Clinical Trial Description

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 study is to determine the safety and reactogenicity of the PfSPZ Vaccine in malaria-experienced healthy adults. The secondary objective is to evaluate vaccine-induced anti-CSP antibody immune responses. The study duration shall be 34 months and subject participation duration shall be 15-26 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02663700
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date April 7, 2016
Completion date December 17, 2018
View Details
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