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

NCT07122986 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Phase 1

Started

2025-08-11

Last updated

2026-04-30

Condition(s) studied

Healthy Participants

Investigational drug(s) / intervention(s)

E coli vaccine 1 Dose AE coli vaccine 1 Dose BE coli vaccine 2E coli vaccine 3E coli Vaccine 4 Dose AE coli Vaccine 4 Dose BE coli Vaccine 4 Dose CE coli Vaccine 5 Dose AE coli Vaccine 5 Dose BPlacebo

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

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

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

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

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

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

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

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

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

Placebo: Placebo administered according to a 0, 6-month interval

Study 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

Sex

ALL

Min age

18 Years

Max age

64 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Percentage of participants reporting prespecified local events within 7 days following each vaccination — 7 days after each vaccination
Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination
Percentage of participants reporting prespecified systemic events within 7 days following each vaccination — 7 days after each vaccination
Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) following each vaccination
Percentage of participants reporting Adverse Events (AEs) from vaccination 1 through 1 month after the last dose of study intervention — From signing of ICD to 1 month after the last assigned vaccination
Adverse events occurring up to 1 month after the last dose of study intervention
Percentage of participants reporting Medically Attended Adverse Events (MAEs) from vaccination 1 through 12 months after the last dose of study intervention — Baseline up to month 18 with final visit being 12 months after last assigned vaccination
MAEs occurring up to 12 months after the last dose of study intervention
Percentage of participants reporting Serious Adverse Events (SAEs) from vaccination 1 through 12 months after the last dose of study intervention — Baseline up to month 18 with final visit being 12 months after last assigned vaccination
SAEs occurring up to 12 months after the last dose of study intervention

Trial sites (11)

Facility	City	Region	Status
Anaheim Clinical Trials, LLC	Anaheim	California	Recruiting
Orange County Research Center	Lake Forest	California	Recruiting
Diablo Clinical Research, Inc.	Walnut Creek	California	Recruiting
Miami Eye Institute	Hollywood	Florida	Recruiting
Research Centers of America	Hollywood	Florida	Recruiting
NYU Langone Health	New York	New York	Recruiting
CTI Clinical Research Center	Cincinnati	Ohio	Recruiting
Senders Pediatrics	South Euclid	Ohio	Recruiting
Alliance for Multispecialty Research, LLC	Knoxville	Tennessee	Recruiting
Alliance for Multispecialty Research, LLC	Knoxville	Tennessee	Recruiting
University Eye Specialists, P.C. (Ophthalmologist)	Maryville	Tennessee	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07122986 on ClinicalTrials.gov ↗ ← All trials in the USA