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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: Active Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT06735209 still lists
NCT06735209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06735209's enrollment target sits among peer trials
22 25th of 27 higher than 3 of 27 other Malaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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