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Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults

Study acronym: LARC-Tu
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 22, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date changed from estimate of Apr 2026 to Mar 12, 2026
    • Study description shortened, about 252 words
    • Study title shortened, about 3 words
    v5
  2. Recruitment opened
    • Start date: Mar 2026 to Apr 2026
    • Site details revised
    v4
  3. Study description expanded, about 2 wordsv3
  4. Primary completion date: Jan 30, 2026 to Sep 30, 2026
    • Start date: Jul 30, 2025 to Mar 2026
    • Study completion date: Jan 30, 2026 to Dec 30, 2026
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy, malaria-naive study participants in Germany by direct venous inoculation (DVI) to determine safety, tolerability, and vaccine efficacy (VE) against controlled human malaria infection (CHMI). 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). The primary objective of the study is to assess the safety and tolerability of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation, in the intention-to-treat (ITT) population.
Trial Details
NCT Number NCT06862453
Lead Sponsor Sanaria Inc.
Collaborators: Universitätsklinikum Tübingen, Institut für Tropenmedizin Wilhelmstrasse, UCLA David Geffen School of Medicine and Fielding School of Public Health, Stanford University, Leiden University
Conditions
(from sponsor)		 Malaria Falciparum
Related terms Malaria, Malaria, Falciparum
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov