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NCT05581641 · ClinicalTrials.gov registry record · Phase 1
Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
A Phase 1 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT05581641 is a Phase 1 study that has completed, run by BioNTech SE. The registered enrollment target is 60 participants.
The verdict
NCT05581641, a Phase 1 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This first-in-human clinical trial, was a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, a ribonucleic acid (RNA)-lipid nanoparticle (LNP) encoding for part of the Plasmodium falciparum circumsporozoite protein (PfCSP). BNT165b1 was evaluated at three dose levels (DLs) to select a safe and tolerable dose in a 3-dose schedule.
Interventions
- OTHER Placebo
- BIOLOGICAL BNT165b1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2024-09-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05581641
The ClinicalTrials.gov registry entry for NCT05581641 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05581641 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05581641 about?
NCT05581641 is a clinical study titled "Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria". This first-in-human clinical trial, was a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, a ribonucleic acid (RNA)-lipid nanoparticle (LNP) encoding for part of the Plasmodium falciparum circumsporozoite protein (...
What is the current status of trial NCT05581641?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-12-15. Estimated completion is 2024-09-06.
What interventions are being tested in trial NCT05581641?
The interventions under investigation include: Placebo (OTHER), BNT165b1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05581641?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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