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NCT06735209 · ClinicalTrials.gov registry record · Phase 1
First-in-Human PfSPZ-LARC2 Vaccination/CHMI
A Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT06735209 is a Phase 1 study of Malaria that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 22 participants, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06735209, a Phase 1 study of Malaria, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized, double-blind, placebo-controlled, Phase 1 trial will enroll up to 22 malaria-naïve, adult participants to test safety, tolerability, immunogenicity, and efficacy of the genetically attenuated Plasmodium falciparum sporozoite vaccine (PfSPZ-LARC2) Vaccine. PfSPZ-LARC2 Vaccine is a late-arresting, replication-competent whole Plasmodium falciparum sporozoite product. We hypothesize that the PfSPZ-LARC2 Vaccine will be safe from breakthrough infection by virtue of deletion of two key parasite genes Mei2 and LINUP and may be more immunogenic and protective than previously tested early arresting sporozoite vaccines. The primary objective is to assess the tolerability and safety of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation.
Conditions Studied
Interventions
- OTHER Sodium Chloride, 0.9%
- BIOLOGICAL PfSPZ Vaccine
- BIOLOGICAL PfSPZ (7G8) Challenge
Study Locations (1)
Washington
- The University of Washington - Virology Research Clinic - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2025-07-23 |
| Est. Completion | 2027-03-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06735209
The ClinicalTrials.gov registry entry for NCT06735209 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (91% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 3 interventions - of which Sodium Chloride, 0.9% is the first listed.
NCT06735209 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT06735209 about?
NCT06735209 is a clinical study titled "First-in-Human PfSPZ-LARC2 Vaccination/CHMI". This randomized, double-blind, placebo-controlled, Phase 1 trial will enroll up to 22 malaria-naïve, adult participants to test safety, tolerability, immunogenicity, and efficacy of the genetically attenuated Plasmodium falciparum sporozoite vaccine (PfSPZ-LARC2) Vaccine. PfSPZ-LARC2 Vaccine is a la...
What is the current status of trial NCT06735209?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2025-07-23. Estimated completion is 2027-03-30.
What conditions does trial NCT06735209 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT06735209?
The interventions under investigation include: Sodium Chloride, 0.9% (OTHER), PfSPZ Vaccine (BIOLOGICAL), PfSPZ (7G8) Challenge (BIOLOGICAL).
Who is sponsoring clinical trial NCT06735209?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06735209 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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