NCT03989102View on ClinicalTrials.gov

Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali

PHASE2CompletedINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

July 3, 2019

Primary Completion Date

April 5, 2022

Study Completion Date

March 17, 2023

Conditions
Malaria
Interventions
BIOLOGICAL

PfSPZ Vaccine

PfSPZ vaccine is comprised of aseptic, metabolically active, non-replicating, purified, cryopreserved P. falciparum sporozoites.

OTHER

Normal Saline

Sterile isotonic (0.9%) normal saline is a clear liquid, making it indistinguishable from the study product when drawn up into a syringe; and will be used as a placebo, rather than a comparator vaccine

Trial Locations (1)

Unknown

Ouelessebougou Health Research Unit, Wolossébougou

All Listed Sponsors
collaborator

Malaria Research and Training Center, Bamako, Mali

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03989102 - Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali | Biotech Hunter | Biotech Hunter