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COMPLETED Phase 2

Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants

NCT05004181 · View on ClinicalTrials.gov ↗

Study Summary

This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who had received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It also evaluated the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who had not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 Omicron variant infection was evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant in RNA COVID-19 vaccine-experienced participants.

Interventions

  • BIOLOGICAL BNT162b2
  • BIOLOGICAL Multivalent BNT162b2 (B.1.1.7 + B.1.617.2)
  • BIOLOGICAL Monovalent BNT162b2 (B.1.1.7)
  • BIOLOGICAL Monovalent BNT162b2 (B.1.617.2)
  • BIOLOGICAL Monovalent BNT162b2 (B.1.1.529.1)

Study Locations (20)

Texas

  • ARC Clinical Research — Austin
  • North Texas Infectious Diseases Consultants — Dallas
  • Clinical Trials of Texas Inc. — San Antonio
  • Diagnostics Research Group — San Antonio

Other

  • CRS Clinical Research Services Berlin — Berlin
  • IKF Institut fuer klinische Forschung Frankfurt — Frankfurt am Main
  • CRS Clinical Research Services Mannheim GmbH — Mannheim
  • Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher — Stuhr

California

  • Collaborative Neuroscience Network LLC — Long Beach
  • California Research Foundation — San Diego

Connecticut

  • Clinical Research Consulting, Llc — Milford
  • Stamford Therapeutics Consortium — Stamford

Georgia

  • Atlanta Center for Medical Research — Atlanta
  • Meridian Clinical Research — Savannah

Mississippi

  • Medpharmics, LLC — Gulfport

New Jersey

  • Amici Clinical Research — Warren Township

New York

  • Rochester Clinical Research — Rochester

Trial Details

FieldValue
Enrollment Target 1,380 participants
Start Date 2021-08-25
Est. Completion 2023-10-04
Phase Phase 2

Sponsor

BioNTech SE

123 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05004181

The ClinicalTrials.gov registry entry for NCT05004181 describes a study currently listed as completed. It is categorized as Phase 2, 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 1,380 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 4 conditions, with COVID-19 appearing as the primary indexed condition, and to 5 interventions — of which BNT162b2 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: NCT05004181 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Texas, Other, California. 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 NCT05004181 about?

NCT05004181 is a clinical study titled "Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants". This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B....

What is the current status of trial NCT05004181?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,380 participants. The study started on 2021-08-25. Estimated completion is 2023-10-04.

What conditions does trial NCT05004181 study?

This clinical trial studies the following conditions: COVID-19, SARS-CoV-2 Infection, SARS-CoV-2 Acute Respiratory Disease, SARS (Disease). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05004181?

The interventions under investigation include: BNT162b2 (BIOLOGICAL), Multivalent BNT162b2 (B.1.1.7 + B.1.617.2) (BIOLOGICAL), Monovalent BNT162b2 (B.1.1.7) (BIOLOGICAL), Monovalent BNT162b2 (B.1.617.2) (BIOLOGICAL), Monovalent BNT162b2 (B.1.1.529.1) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05004181?

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 NCT05004181 being conducted?

This trial has 20 study locations across California, Connecticut, Georgia, Mississippi, New Jersey. 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