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ACTIVE NOT RECRUITING Phase 1

A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

NCT06069544 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 163 participants
Start Date 2023-11-13
Est. Completion 2026-03
Phase Phase 1

Sponsor

BioNTech SE

123 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06069544 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Arizona, Maryland, Nevada. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06069544?

The interventions under investigation include: Placebo (OTHER), BNT165e (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06069544?

This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial