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NCT06069544 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
A Phase 1 study of Malaria, sponsored by BioNTech SE.
- Active
- Registry status
- Phase 1
- Development phase
- 163
- Enrollment target
- 5
- Study locations
NCT06069544: Active Phase 1 study of Malaria, sponsored by BioNTech SE.
NCT06069544 is a Phase 1 study of Malaria that is active but no longer recruiting, run by BioNTech SE. The registered enrollment target is 163 participants, below the 252-participant average among 27 other Malaria trials with a reported enrollment target (35% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06069544, a Phase 1 study of Malaria, is active but no longer recruiting, sponsored by BioNTech SE.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 163 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a randomized, dose-escalation Phase I/IIa trial to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults. The multi-antigen malaria vaccine (designated BNT165e) is a combination of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2), encoding P. falciparum antigens encapsulated in lipid nanoparticles. The BNT165c RNA encodes the full Plasmodium falciparum circumsporozoite protein. The BNT165d1 and BNT165d2 RNAs both encode conserved, immunogenic segments of liver stage-expressed proteins.
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 study participant. Confirmation by an investigator or medically qualified person was required for all Grade 3 or 4 reactogenicity events. Grades were defined as: Grade 1 - Mild; does
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL BNT165e
Study Locations (5)
Arizona
- AMR Tempe - Tempe
Maryland
- University of Maryland, Center for Vaccine Development - Baltimore
Nevada
- AMR Las Vegas - Las Vegas
Tennessee
- AMR Knoxville - Knoxville
Texas
- Clinical Trials of Texas - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2023-11-13 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What the registry record for NCT06069544 still lists
NCT06069544 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 27 other Malaria trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06069544 lists 5 locations in 5 states (Arizona, Maryland, Nevada).
Frequently Asked Questions
What is clinical trial NCT06069544 about?
NCT06069544 is a clinical study titled "A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria". This is a randomized, dose-escalation Phase I/IIa trial to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults. The multi-antigen malaria vaccine (designated BNT165e) is ...
What is the current status of trial NCT06069544?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 163 participants. The study started on 2023-11-13. Estimated completion is 2026-03.
What conditions does trial NCT06069544 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT06069544?
The interventions under investigation include: Placebo (OTHER), BNT165e (BIOLOGICAL).
Who is sponsoring clinical trial NCT06069544?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06069544 being conducted?
This trial has 5 study locations across Arizona, Maryland, Nevada, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06069544's enrollment target sits among peer trials
163 7th of 27 higher than 21 of 27 other Malaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malaria 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.
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