Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
Public ClinicalTrials.gov record NCT05581641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Exploratory Phase I, Randomized, Observer-blind, Placebo-controlled Dose Escalation Trial Evaluating the Safety, Tolerability and Immunogenicity of an Investigational RNA-based Vaccine for Active Immunization Against Malaria
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05581641
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 60 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 14, 2022
- Primary completion
- Feb 22, 2024
- Completion
- Sep 5, 2024
- Last update posted
- Sep 2, 2025
2022 – 2024
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC | Tempe | Arizona | 85281 | — |
| University of Maryland, Center for Vaccine Development | Baltimore | Maryland | 21201 | — |
| Alliance for Multispecialty Research, LLC | Las Vegas | Nevada | 89119 | — |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37909 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05581641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05581641 live on ClinicalTrials.gov.