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New mRNA flu vaccine shows promise in early human trial

NCT ID NCT06602531

Vaccine Sponsor: Arcturus Therapeutics, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This early-stage trial tested a new self-amplifying mRNA vaccine (ARCT-2304) designed to protect against pandemic influenza. 212 healthy adults aged 18-80 received either two doses of the experimental vaccine or one dose of a licensed flu vaccine plus placebo. Researchers monitored safety and immune responses to find the best dose and schedule for future studies.

What this could mean

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

Active substance
Self-amplifying mRNA pandemic influenza vaccine (ARCT-2304)
What this could lead to
If successful, this could lead to a faster, more effective vaccine against pandemic influenza strains.
What could go wrong
This is an early phase 1 trial with only 212 participants, so safety and immune response are still being explored. The vaccine may not produce strong enough immunity 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

212 people

The number who actually took part.

Started

Dec 2024

Finished

Dec 2025

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 to 80 years

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.

Main Inclusion Criteria: * Individuals are male or female adults 18-80 years of age. * Healthy participants or participants with pre-existing stable medical conditions. * Individuals of childbearing potential must be willing to adhere to contraceptive requirements. Main Exclusion Criteria: * Individuals with acute medical conditions or febrile illness, including body temperature ≥100.4°F (≥38.0°C measured by any method) within 3 days prior to randomization. * Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any mRNA vaccine, influenza vaccine, or excipients. * Individuals with a history of myocarditis, pericarditis, myopericarditis, or cardiomyopathy. * Individuals who received any influenza vaccine within 3 months prior to first vaccine administration or plan to receive an influenza vaccine during the study period. * Individuals who have received mRNA vaccination within 60 days before the first vaccine administration. * Individuals who have received or plan to receive an A/H5N1 influenza vaccine and/or individuals who had substantial exposure to or direct contact with poultry, wild birds, live cattle, or raw milk.

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

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

Influenza, human

Contacts and locations

Locations

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Tekton Research

    Longmont, Colorado, 80501, United States

  • Velocity Clinical Research

    La Mesa, California, 91942, United States

  • Velocity Clinical Research

    San Bernardino, California, 92408, United States

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