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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: Completed Phase 1 study, sponsored by BioNTech SE.
NCT05581641 is a Phase 1 study that has completed, run by BioNTech SE. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial part
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 |
What the finished NCT05581641 record still lists
NCT05581641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05581641 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05581641's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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