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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: Clinical Trial Phase 1 study, sponsored by Sanaria.
NCT05604521 is a Phase 1 study that was terminated before completion, run by Sanaria. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The differences in proportions of vaccinees compared to controls experiencing related moderate, severe, or serious solicited and unsolicited adverse events and laboratory abnormalities after vaccination.
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 |
Why NCT05604521 stopped before completion
NCT05604521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Normal Saline is the first listed.
NCT05604521 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05604521's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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