Vaccine to prevent E. coli infection 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

This phase 1 test gives several experimental E. coli vaccines by injection to healthy adults ages 18–64 to see if they are safe and well tolerated.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Pfizer (industry)
• Locations: 11 sites (Anaheim, California and 10 other locations)
• Trial ID: NCT07122986 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, first-in-human safety trial of multiple investigational intramuscular E. coli vaccine formulations and dose schedules in healthy adults. Participants will receive one of several vaccine doses and be monitored for adverse events, local and systemic reactions, and basic laboratory safety measures. The primary goal is to characterize tolerability and short-term safety rather than to demonstrate protection against infection. Enrollment is limited to adults 18–64 who are medically healthy and not pregnant, and the study is sponsored by Pfizer and conducted at clinical research sites in California.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 64 who have no immune deficiency, are not pregnant or breastfeeding, and have no history of severe allergic reactions to vaccines or vaccine components.

Not a fit: People who are immunocompromised, pregnant or breastfeeding, outside the 18–64 age range, or with a history of severe vaccine allergy are unlikely to be eligible or to receive benefit from this phase 1 safety trial.

Why it matters

Potential benefit: If successful, the vaccines could advance toward later trials and eventually provide a preventive option against E. coli infections.

How similar studies have performed: Previous E. coli vaccine candidates have produced immune responses in some early trials but none are yet widely licensed, so this approach builds on but does not yet have established success.

Eligibility criteria

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.

Where this trial is running

Anaheim, California and 10 other locations

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

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions: Healthy Participants