Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea.

PHASE1CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

December 31, 2017

Study Completion Date

February 28, 2018

Conditions
Malaria
Interventions
BIOLOGICAL

PfSPZ Vaccine

Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine)

BIOLOGICAL

PfSPZ Challenge (for CHMI)

live, infectious, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Challenge) Controlled human malaria infection (CHMI) by direct venous inoculation of 3,200 PfSPZ Challenge

OTHER

Normal Saline

0.9% Sodium chloride

BIOLOGICAL

PfSPZ Challenge (for PfSPZ-CVac)

live, infectious, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Challenge)

Trial Locations (1)

Unknown

La Paz Medical Center, Malabo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ifakara Health Institute

OTHER

collaborator

Swiss Tropical & Public Health Institute

OTHER

collaborator

Government of Equatorial Guinea

OTHER_GOV

collaborator

Marathon Oil Corporation

INDUSTRY

collaborator

Noble Oil Services

INDUSTRY

collaborator

La Paz Medical Center, Malabo, Equatorial Guinea

UNKNOWN

lead

Sanaria Inc.

INDUSTRY