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New mRNA flu shot enters first human tests

NCT ID NCT05426174

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tested a new mRNA-based flu vaccine in 233 healthy adults aged 18 and older. The study compared three different doses of the experimental vaccine to a standard high-dose flu shot. Researchers monitored safety and immune responses over time to see if the new vaccine could be a promising option for flu prevention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA NA vaccine
What this could lead to
If successful, this could lead to a new type of flu vaccine that may offer better protection against influenza.
What could go wrong
This is an early Phase 1 trial with only 233 participants, so safety and effectiveness are not yet proven. The vaccine may not work as hoped or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

233 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 18 years or older on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: 1. Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR 2. Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration * A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before administration of study intervention. * Informed consent form has been signed and dated. Exclusion Criteria: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Moderate or severe acute illness/infection (according to investigator judgement) or febrile illness (temperature ≥100.4°F) on the day of study intervention administration. * Have known or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. * Have any diagnosis, current or past, of autoimmune disease. * Body mass index of 40 kg/m2 or higher. * Receipt of immune globulins, blood, or blood-derived products in the past 3 months. * Have taken high-dose inhaled corticosteroid (≥500 μg of fluticasone) within 6 months prior to study vaccination. * Self-reported or documented seropositivity for HIV, hepatitis B virus, or hepatitis C virus.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AES - DRS - Optimal Research_Site 8400001

    Peoria, Illinois, 61614-4885, United States

  • AES - DRS - Optimal Research_Site 8400002

    Melbourne, Florida, 32934-8172, United States

  • AES - DRS - Optimal Research_Site 8400007

    Huntsville, Alabama, 35802, United States

  • Central Phoenix Medical Clinic, LLC_Site: 8400010

    Phoenix, Arizona, 85020, United States

  • Optimal Research San Diego, LLC_Site: 8400009

    San Diego, California, 92108, United States

  • Synexus Clinical Research_Site 8400003

    Cincinnati, Ohio, 45236, United States

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