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NCT05604521 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI
A Phase 1 study, sponsored by Sanaria.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT05604521 is a Phase 1 study that was terminated before completion, run by Sanaria. The registered enrollment target is 31 participants.
The verdict
NCT05604521, a Phase 1 study, was terminated before completion, sponsored by Sanaria.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity, and vaccine efficacy (VE) against heterologous controlled human malaria infection (CHMI) with the 7G8 clone of Plasmodium falciparum (Pf) conducted at 3 or 12 weeks after the third immunization. The trial is designed to determine if individuals living in a non-malaria endemic area such as the United States (US) are protected against heterologous CHMI conducted at these time points.
Interventions
- OTHER Normal Saline
- BIOLOGICAL PfSPZ Vaccine
- BIOLOGICAL PfSPZ Challenge (7G8)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-12-06 |
| Est. Completion | 2023-09-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05604521
The ClinicalTrials.gov registry entry for NCT05604521 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanaria, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Normal Saline is the first listed.
NCT05604521 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05604521 about?
NCT05604521 is a clinical study titled "A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI". USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity, and vaccine efficacy (VE) against heterologous controlled human malaria infection (CH...
What is the current status of trial NCT05604521?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2022-12-06. Estimated completion is 2023-09-05.
What interventions are being tested in trial NCT05604521?
The interventions under investigation include: Normal Saline (OTHER), PfSPZ Vaccine (BIOLOGICAL), PfSPZ Challenge (7G8) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05604521?
This trial is sponsored by Sanaria, which has 5 total clinical trials registered on ClinicalTrials.gov.
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