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A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
NCT05997290 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 1,051 participants |
| Start Date | 2023-08-10 |
| Est. Completion | 2025-03-13 |
| Phase | Phase 2 |
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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. 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 1,051 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 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. 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: NCT05997290 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Alabama. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05997290?
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 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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