New mRNA flu shot enters first human tests
NCT ID NCT05426174
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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233 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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AES - DRS - Optimal Research_Site 8400001
Peoria, Illinois, 61614-4885, United States
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AES - DRS - Optimal Research_Site 8400002
Melbourne, Florida, 32934-8172, United States
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AES - DRS - Optimal Research_Site 8400007
Huntsville, Alabama, 35802, United States
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Central Phoenix Medical Clinic, LLC_Site: 8400010
Phoenix, Arizona, 85020, United States
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Optimal Research San Diego, LLC_Site: 8400009
San Diego, California, 92108, United States
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Synexus Clinical Research_Site 8400003
Cincinnati, Ohio, 45236, United States
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