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NCT04966871 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
A Phase 1 study, sponsored by Sanaria.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT04966871 is a Phase 1 study that has completed, run by Sanaria. The registered enrollment target is 54 participants.
The verdict
NCT04966871, a Phase 1 study, has completed, sponsored by Sanaria.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a randomized, double blind, placebo-controlled, single site, trial of a condensed regimen of 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) conducted at varying time intervals after the third immunization (14, 42 or 70 days). The trial is designed to simulate pre-deployment immunization of military personnel. Prior studies with this regimen show high level protection (\>80%) against CHMI at 21 days, but the onset and duration of protection have not been fully defined.
Interventions
- OTHER Normal Saline
- BIOLOGICAL PfSPZ Vaccine
- BIOLOGICAL PfSPZ Challenge (7G8) for CHMI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-09-27 |
| Est. Completion | 2022-06-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04966871
The ClinicalTrials.gov registry entry for NCT04966871 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 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.
NCT04966871 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04966871 about?
NCT04966871 is a clinical study titled "Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults". This is a randomized, double blind, placebo-controlled, single site, trial of a condensed regimen of 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 malari...
What is the current status of trial NCT04966871?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2021-09-27. Estimated completion is 2022-06-21.
What interventions are being tested in trial NCT04966871?
The interventions under investigation include: Normal Saline (OTHER), PfSPZ Vaccine (BIOLOGICAL), PfSPZ Challenge (7G8) for CHMI (BIOLOGICAL).
Who is sponsoring clinical trial NCT04966871?
This trial is sponsored by Sanaria, which has 5 total clinical trials registered on ClinicalTrials.gov.
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