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New e. coli vaccine enters first human safety trial

NCT ID NCT07122986

Vaccine Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

Pfizer is testing several experimental vaccines designed to protect against E. coli bacteria. This early-stage study involves 310 healthy adults aged 18 to 64. The main goal is to check if the vaccines are safe and tolerable, not yet whether they work. Participants will receive two shots six months apart and be monitored for side effects like injection-site pain, fever, and fatigue.

What this could mean

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

Active substance
E. coli vaccine
What this could lead to
If this vaccine proves safe and effective, it could help prevent E. coli infections, which can cause severe diarrhea and kidney damage.
What could go wrong
This is an early Phase 1 trial focused only on safety in healthy adults. It is too soon to know if the vaccine actually prevents infection, and side effects are possible.

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

About 310 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

May 2028

An estimate. End dates often move.

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 64 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.

Ages Eligible for Study: 18 to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Key Inclusion Criteria 1. Adult Participants \>= 18 through \< 64 years of age at the time of enrollment. 2. Healthy participants as determined by medical history, physical examination, and clinical judgement of the investigator to be eligible for inclusion in the study. Key Exclusion Criteria 1. Severe adverse reaction history associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 2. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 3. Women who are pregnant, plan to become pregnant during the study, or are breastfeeding.

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Conditions

The condition(s) this trial relates to.

escherichia coli infection prevention target

As listed by the trial registrant

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

Healthy participants

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alliance for Multispecialty Research, LLC

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Alliance for Multispecialty Research, LLC

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • Anaheim Clinical Trials, LLC

    RECRUITING

    Anaheim, California, 92801, United States

  • CTI Clinical Research Center

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • Diablo Clinical Research, Inc.

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Miami Eye Institute

    RECRUITING

    Hollywood, Florida, 33024, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Orange County Research Center

    RECRUITING

    Lake Forest, California, 92630, United States

  • Research Centers of America

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Senders Pediatrics

    RECRUITING

    South Euclid, Ohio, 44121, United States

  • University Eye Specialists, P.C. (Ophthalmologist)

    RECRUITING

    Maryville, Tennessee, 37803, United States

More trials for these conditions

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