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NCT05997290 · ClinicalTrials.gov registry record · Phase 2

A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

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

Completed
Registry status
Phase 2
Development phase
1,051
Enrollment target
20
Study locations

NCT05997290 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 1,051 participants, below the 55,209-participant average among 203 other COVID-19 trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT05997290, 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
1,051 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people. Substudy A: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1). * The study is about 6 months long for each participant. * Participants will have at least 5 visits to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken. Substudy B: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who are COVID-19 vaccine-naïve * who have had any positive SARS-CoV-2 test result \>28 days before study vaccine administration. * The study is about 6 months long for each participant. * Participants will have at least 5 visits to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken. Substudy C: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to: * Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2). * Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the stu

Conditions Studied

COVID-19 SARS CoV 2 Infection

Interventions

  • BIOLOGICAL BNT162b2 (Omi XBB.1.5)
  • BIOLOGICAL BNT162b2 (Omi JN.1)
  • BIOLOGICAL BNT162b2 (Omi KP.2)

Study Locations (20)

Florida

  • Indago Research & Health Center, Inc - Hialeah
  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare - Jacksonville
  • Care Research - West Flagler Street - Miami
  • Acevedo Clinical Research Associates - Miami
  • Clinical Neuroscience Solutions, Inc. - Orlando

California

  • West Coast Research - Dublin
  • California Research Foundation - San Diego
  • Bayview Research Group, LLC - Valley Village
  • Diablo Clinical Research, Inc. - Walnut Creek

Alabama

  • North Alabama Research Center - Athens
  • Medical Affiliated Research Center - Huntsville
  • Alliance for Multispecialty Research, LLC - Mobile

Arizona

  • Epic Medical Research - Surprise - Surprise
  • Alliance for Multispecialty Research, LLC - Tempe

Missouri

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO - Springfield
  • Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only) - Springfield

Connecticut

  • Clinical Research Consulting - Milford

Georgia

  • Clinical Research Atlanta - Stockbridge

Hawaii

  • East-West Medical Research Institute - Honolulu

Trial Details

FieldValue
Enrollment Target 1,051 participants
Start Date 2023-08-10
Est. Completion 2025-03-13
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 NCT05997290

The ClinicalTrials.gov registry entry for NCT05997290 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,051 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,209-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 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 3 interventions - of which BNT162b2 (Omi XBB.1.5) is the first listed.

NCT05997290 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT05997290 about?

NCT05997290 is a clinical study titled "A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals". The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people. Substudy A: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 ...

What is the current status of trial NCT05997290?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,051 participants. The study started on 2023-08-10. Estimated completion is 2025-03-13.

What conditions does trial NCT05997290 study?

This clinical trial studies the following conditions: COVID-19, SARS CoV 2 Infection.

What interventions are being tested in trial NCT05997290?

The interventions under investigation include: BNT162b2 (Omi XBB.1.5) (BIOLOGICAL), BNT162b2 (Omi JN.1) (BIOLOGICAL), BNT162b2 (Omi KP.2) (BIOLOGICAL).

Who is sponsoring clinical trial NCT05997290?

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

Where is trial NCT05997290 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. 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.