RecruitingPhase 1NCT07122986

A Study to Learn About a Vaccine Against E Coli in Healthy Adults

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A VACCINE AGAINST E COLI IN HEALTHY ADULTS


Sponsor

Pfizer

Enrollment

310 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study evaluates an investigational vaccine designed to protect against Escherichia coli (E coli). The primary objective is to assess the safety and tolerability of E coli vaccines administered intramuscularly to healthy adults.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria3

  • Ages Eligible for Study: 18 to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes
  • Adult Participants >= 18 through < 64 years of age at the time of enrollment.
  • Healthy participants as determined by medical history, physical examination, and clinical judgement of the investigator to be eligible for inclusion in the study.

Exclusion Criteria3

  • Severe adverse reaction history associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  • Women who are pregnant, plan to become pregnant during the study, or are breastfeeding.

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Interventions

DRUGE coli vaccine 1 Dose A

Candidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval

DRUGE coli vaccine 1 Dose B

Candidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval

DRUGE coli vaccine 2

Candidate E coli vaccine 2, administered according to a 0, 6-month interval

DRUGE coli vaccine 3

Candidate E coli vaccine 3, administered according to a 0, 6-month interval

DRUGE coli Vaccine 4 Dose A

Candidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval

DRUGE coli Vaccine 4 Dose B

Candidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval

DRUGE coli Vaccine 4 Dose C

Candidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval

DRUGE coli Vaccine 5 Dose A

Candidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval

DRUGE coli Vaccine 5 Dose B

Candidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval

DRUGPlacebo

Placebo administered according to a 0, 6-month interval


Locations(11)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Orange County Research Center

Lake Forest, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Miami Eye Institute

Hollywood, Florida, United States

Research Centers of America

Hollywood, Florida, United States

NYU Langone Health

New York, New York, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Senders Pediatrics

South Euclid, Ohio, United States

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States

University Eye Specialists, P.C. (Ophthalmologist)

Maryville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT07122986


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