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Sanofi mRNA vaccine trial ends early – what we know

NCT ID NCT04798027

Vaccine Sponsor: Sanofi Pasteur, a Sanofi Company 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study tested Sanofi's experimental mRNA vaccine against COVID-19 in 182 healthy adults aged 18 and older. The main goals were to check safety and measure the body's immune response. The trial was terminated early, so full results are not available.

What this could mean

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

Active substance
SARS-CoV-2 mRNA vaccine
What this could lead to
If successful, this could lead to a new mRNA vaccine option for COVID-19.
What could go wrong
This was an early (Phase 1/2) trial that was terminated, so results are limited. It is unclear if the vaccine would have been effective or safe in larger studies.

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

182 people

The number who actually took part.

Started

Mar 2021

Finished

Jun 2022

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 on the day of inclusion. * A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: * Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile. OR * Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination. A participant of childbearing potential must had a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the study intervention. * Informed Consent Form had been signed and dated. * Participant not eligible to receive, based on local guidance, or if eligible does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination until completion of the key timepoint of Day 43 of follow-up of this study. Exclusion criteria: * History of COVID-19 disease or prior SARS-CoV-2 infection confirmed serologically. * 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). * Chronic illness or condition considered to potentially increase the risk for severe COVID illness or that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. * Known liver disease or fatty liver. * Positive test for chronic active Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody from blood work collected at screening visit. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on Investigator's judgment. * Receipt of immunoglobulins, blood or blood-derived products in the past 3 months. * Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome coronavirus \[MERS-CoV\]). * Receipt of any vaccine in the 30 days preceding the first study vaccination or planned receipt of any vaccine in the 30 days following the last study vaccination except for influenza vaccination, which might be received at least 2 weeks before and a minimum of 2 weeks after study vaccines. * Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood draw or planned use of such therapy 72 hours prior to study immunogenicity blood draws at Day 22 and Day 36. * Residence in a nursing home or long-term care facility. * Health care workers providing direct patient care for COVID-19 participants. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

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

COVID -19

Contacts and locations

Locations

  • Investigational Site Number :0360001

    Melbourne, Victoria, 3010, Australia

  • Investigational Site Number :0360002

    Nedlands, Western Australia, 6009, Australia

  • Investigational Site Number :0360003

    Morayfield, Queensland, 4506, Australia

  • Investigational Site Number :0360005

    South Brisbane, Queensland, 4101, Australia

  • Investigational Site Number :0760001

    Salvador, Estado de Bahia, 40415-006, Brazil

  • Investigational Site Number :0760003

    Belo Horizonte, Minas Gerais, 30110-063, Brazil

  • Investigational Site Number :0760004

    Campo Grande, Mato Grosso do Sul, 79070-900, Brazil

  • Investigational Site Number :3400001

    San Pedro Sula, 21104, Honduras

  • Investigational Site Number :3400002

    Barrio del Centro, 11101, Honduras

  • Investigational Site Number :8400001

    Rochester, New York, 14609, United States

  • Investigational Site Number :8400002

    Hollywood, Florida, 33024, United States

  • Investigational Site Number :8400003

    Rolling Hills Estates, California, 90274, United States

  • Investigational Site Number :8400004

    North Charleston, South Carolina, 29405, United States

  • Investigational Site Number :8400005

    Salt Lake City, Utah, 84107, United States

  • Investigational Site Number :8400006

    Miami, Florida, 33135, United States

  • Investigational Site Number :8400007

    Kansas City, Missouri, 64114, United States

  • Investigational Site Number :8400008

    Omaha, Nebraska, 68134, United States

  • Investigational Site Number :8400009

    Houston, Texas, 77081, United States

  • Investigational Site Number :8400010

    Philadelphia, Pennsylvania, 19104, United States

  • Investigational Site Number :8400015

    Knoxville, Tennessee, 37920, United States

  • Investigational Site Number :8400017

    Iowa City, Iowa, 52242, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.