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Sanofi's COVID-19 vaccine shows promise in early trial

NCT ID NCT04537208

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new COVID-19 vaccine made from a piece of the virus's spike protein, given with or without an immune booster (adjuvant). 441 healthy adults aged 18 and older received one of several vaccine formulas. The goal was to see how well the vaccine triggered an immune response and whether it was safe over 12 months.

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 recombinant protein vaccine with or without adjuvant (AF03 or AS03)
What this could lead to
If successful, this vaccine could help protect against COVID-19 by triggering a strong immune response.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 441 participants, so results may not apply to larger populations. The vaccine may not provide lasting protection or work against new variants.

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

441 people

The number who actually took part.

Started

Sep 2020

Finished

Nov 2021

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 of age or older on the day of inclusion. * Informed consent form had been signed and dated. * Able to attend all scheduled visits and complied with all study procedures. Exclusion Criteria: * Participant was pregnant, or lactating, or of childbearing potential and not used an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination. To be considered of non-childbearing potential, a female was post-menopausal for at least 1 year or surgically sterile. * 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. * Prior administration of a coronavirus vaccine SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome). * 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). * History of SARS-CoV-2 infection, confirmed either clinically, serologically, or microbiologically * Chronic illness or condition considered to potentially increase the risk for severe COVID illness or that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion. * Receipt of any therapy known to had in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood drew. * Health care workers provided direct participant 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 (healthy volunteers)

Contacts and locations

Locations

  • Investigational Site Number 8400001

    Rochester, New York, 14609, United States

  • Investigational Site Number 8400002

    Omaha, Nebraska, 68134, United States

  • Investigational Site Number 8400003

    Philadelphia, Pennsylvania, 19104, United States

  • Investigational Site Number 8400004

    Birmingham, Alabama, 35294, United States

  • Investigational Site Number 8400007

    Rochester, New York, 14642, United States

  • Investigational Site Number 8400008

    Cleveland, Ohio, 44122, United States

  • Investigational Site Number 8400011

    Hollywood, Florida, 33024, United States

  • Investigational Site Number 8400012

    Rolling Hills Estates, California, 90274, United States

  • Investigational Site Number 8400014

    Mt. Pleasant, South Carolina, 29464, United States

  • Investigational Site Number 8400016

    Boston, Massachusetts, 02115, United States

  • Investigational Site Number 8400019

    Melbourne, Florida, 32934, United States