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NCT05004181 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of COVID-19 and SARS CoV 2 Infection, sponsored by BioNTech SE.

Completed
Registry status
Phase 2
Development phase
1,380
Enrollment target
20
Study locations

NCT05004181 is a Phase 2 study of COVID-19 and SARS CoV 2 Infection that has completed, run by BioNTech SE. The registered enrollment target is 1,380 participants, below the 55,208-participant average among 203 other COVID-19 trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT05004181, a Phase 2 study of COVID-19 and SARS CoV 2 Infection, has completed, sponsored by BioNTech SE.

COMPLETED
Registry status
Phase 2
Development phase
1,380 participants
Enrollment target
20
Study locations

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.

Conditions Studied

COVID-19 SARS CoV 2 Infection SARS-CoV-2 Acute Respiratory Disease SARS (Disease)

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

53 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, categorized as Phase 2. The registered enrollment target is 1,380 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,208-participant average among 203 other COVID-19 trials with a reported enrollment target (98% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.

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.

NCT05004181 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Texas, Other, California.

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).

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).

Who is sponsoring clinical trial NCT05004181?

This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.