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

NCT07122986 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: C5211001
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (5)

• Percentage of participants reporting prespecified local events within 7 days following each vaccination

  Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination

  7 days after each vaccination

• Percentage of participants reporting prespecified systemic events within 7 days following each vaccination

  Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) following each vaccination

  7 days after each vaccination

• Percentage of participants reporting Adverse Events (AEs) from vaccination 1 through 1 month after the last dose of study intervention

  Adverse events occurring up to 1 month after the last dose of study intervention

  From signing of ICD to 1 month after the last assigned vaccination

• Percentage of participants reporting Medically Attended Adverse Events (MAEs) from vaccination 1 through 12 months after the last dose of study intervention

  MAEs occurring up to 12 months after the last dose of study intervention

  Baseline up to month 18 with final visit being 12 months after last assigned vaccination

• Percentage of participants reporting Serious Adverse Events (SAEs) from vaccination 1 through 12 months after the last dose of study intervention

  SAEs occurring up to 12 months after the last dose of study intervention

  Baseline up to month 18 with final visit being 12 months after last assigned vaccination

Study Arms (10)

E coli vaccine 1 Dose A

EXPERIMENTAL

Candidate E coli vaccine on day 1 and day 180

Drug: E coli vaccine 1 Dose A

E coli vaccine 1 Dose B

EXPERIMENTAL

Candidate E coli vaccine on day 1 and day 180

Drug: E coli vaccine 1 Dose B

E coli vaccine 2

EXPERIMENTAL

Candidate E coli vaccine on day 1 and day 180

Drug: E coli vaccine 2

E coli vaccine 3

EXPERIMENTAL

Candidate E coli vaccine on day 1 and day 180

Drug: E coli vaccine 3

E coli Vaccine 4 Dose A

EXPERIMENTAL

Candidate E coli vaccine on day 1 and day 180

Drug: E coli Vaccine 4 Dose A

E coli Vaccine 4 Dose B

EXPERIMENTAL

Candidate E coli vaccine on day 1 and day 180

Drug: E coli Vaccine 4 Dose B

E coli Vaccine 4 Dose C

EXPERIMENTAL

Candidate E coli vaccine on day 1 and day 180

Drug: E coli Vaccine 4 Dose C

E coli Vaccine 5 Dose A

EXPERIMENTAL

Drug: E coli Vaccine 5 Dose A

E coli Vaccine 5 Dose B

EXPERIMENTAL

Drug: E coli Vaccine 5 Dose B

Placebo

EXPERIMENTAL

Placebo received on day 1 and day 180

Drug: Placebo

Interventions

E coli vaccine 1 Dose A DRUG

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

E coli vaccine 1 Dose A

E coli Vaccine 5 Dose A DRUG

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

E coli Vaccine 5 Dose A

E coli Vaccine 5 Dose B DRUG

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

E coli Vaccine 5 Dose B

Placebo DRUG

Placebo administered according to a 0, 6-month interval

Placebo

E coli vaccine 1 Dose B DRUG

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

E coli vaccine 1 Dose B

E coli vaccine 2 DRUG

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

E coli vaccine 2

E coli vaccine 3 DRUG

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

E coli vaccine 3

E coli Vaccine 4 Dose A DRUG

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

E coli Vaccine 4 Dose A

E coli Vaccine 4 Dose B DRUG

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

E coli Vaccine 4 Dose B

E coli Vaccine 4 Dose C DRUG

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

E coli Vaccine 4 Dose C

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult Participants \>= 18 through \< 64 years of age at the time of enrollment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

RECRUITING

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

RECRUITING

Miami Eye Institute

Hollywood, Florida, 33024, United States

RECRUITING

Research Centers of America

Hollywood, Florida, 33024, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

RECRUITING

Senders Pediatrics

South Euclid, Ohio, 44121, United States

RECRUITING

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37909, United States

RECRUITING

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

RECRUITING

University Eye Specialists, P.C. (Ophthalmologist)

Maryville, Tennessee, 37803, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): May 26, 2028
• Study Completion (Estimated): May 26, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)