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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: Completed Phase 2 study of COVID-19 and SARS CoV 2 Infection, sponsored by BioNTech SE.
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 38,460-participant average among 298 other COVID-19 trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Local reactions of any grade are reported. Local reactions were graded using criteria based on the US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of systemic reactions was based on the participant's assessments collected in the electronic diary (e-diary) or mapped from the adverse ev
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,380 participants |
| Start Date | 2021-08-25 |
| Est. Completion | 2023-10-04 |
| Phase | Phase 2 |
What the finished NCT05004181 record still lists
NCT05004181 is an interventional study that assigns participants to a tested intervention. Its 1,380 participants enrollment target places it among the larger protocols in the corpus, below the 38,460-participant average among 298 other COVID-19 trials with a reported enrollment target (96% lower).
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 names 20 study sites across 11 states, led by 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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participants (enrollment target), bucketed by value
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