NCT03510481View on ClinicalTrials.gov

Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali

PHASE1CompletedINTERVENTIONAL
Enrollment

478

Participants

Timeline

Start Date

May 14, 2018

Primary Completion Date

November 23, 2019

Study Completion Date

February 13, 2020

Conditions
Malaria
Interventions
BIOLOGICAL

PfSPZ Vaccine

PfSPZ Vaccine is Radiation attenuated, aseptic, purified, vialed, cryopreserved, NF54 P. falciparum sporozoites produced by Sanaria, Inc.

DRUG

Normal Saline

Clear liquid indistinguishable from the study product will be used as a placebo rather than a comparator vaccine.

DRUG

artemether 20mg/lumefantrine 120mg (AL)

Licensed antimalarial in the US and Mali for use for uncomplicated malaria.

Trial Locations (1)

Unknown

Malaria Research and Training Center, Bamako

All Listed Sponsors
collaborator

Sanaria Inc.

INDUSTRY

collaborator

Malaria Research and Training Center, Bamako, Mali

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03510481 - Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali | Biotech Hunter | Biotech Hunter