Safety, Tolerability and Efficacy Against Controlled Human Malaria Infection of PfSPZ-LARC2 Vaccine in Malaria-naïve Adults

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

July 30, 2025

Primary Completion Date

January 30, 2026

Study Completion Date

January 30, 2026

Conditions
Malaria Falciparum
Interventions
OTHER

Normal Saline (Placebo)

The blinded control group (n = 6) of the main cohort will receive normal saline as placebo, also by DVI.

BIOLOGICAL

PfSPZ-LARC2 Vaccine

Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) contains a deletion of two genes, the Mei2 and LINUP genes, and undergoes developmental arrest in the late liver stages without releasing merozoites into the blood stream (blood stage parasites).

BIOLOGICAL

PfSPZ Challenge (NF54)

Main cohort participants will undergo homologous CHMI using DVI of 3.2x10\^3 PfSPZ of PfSPZ Challenge (NF54), which are infectious cryopreserved Pf sporozoites.

Trial Locations (1)

72074

University of Tubingen, Wilhelmstraße 27

All Listed Sponsors
collaborator

Universitätsklinikum Tübingen, Institut für Tropenmedizin Wilhelmstrasse

UNKNOWN

collaborator

UCLA David Geffen School of Medicine and Fielding School of Public Health

UNKNOWN

collaborator

Stanford University

OTHER

collaborator

Leiden University

OTHER

lead

Sanaria Inc.

INDUSTRY

NCT06862453 - Safety, Tolerability and Efficacy Against Controlled Human Malaria Infection of PfSPZ-LARC2 Vaccine in Malaria-naïve Adults | Biotech Hunter | Biotech Hunter