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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06069544
The ClinicalTrials.gov registry entry for NCT06069544 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 252-participant average among 27 other Malaria trials with a reported enrollment target (35% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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