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

Purpose

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.

Condition

  • Healthy Participants

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
E coli vaccine 1 Dose A 		Candidate E coli vaccine on day 1 and day 180
  • Drug: E coli vaccine 1 Dose A
    Candidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval
Experimental
E coli vaccine 1 Dose B 		Candidate E coli vaccine on day 1 and day 180
  • Drug: E coli vaccine 1 Dose B
    Candidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval
Experimental
E coli vaccine 2 		Candidate E coli vaccine on day 1 and day 180
  • Drug: E coli vaccine 2
    Candidate E coli vaccine 2, administered according to a 0, 6-month interval
Experimental
E coli vaccine 3 		Candidate E coli vaccine on day 1 and day 180
  • Drug: E coli vaccine 3
    Candidate E coli vaccine 3, administered according to a 0, 6-month interval
Experimental
E coli Vaccine 4 Dose A 		Candidate E coli vaccine on day 1 and day 180
  • Drug: E coli Vaccine 4 Dose A
    Candidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval
Experimental
E coli Vaccine 4 Dose B 		Candidate E coli vaccine on day 1 and day 180
  • Drug: E coli Vaccine 4 Dose B
    Candidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval
Experimental
E coli Vaccine 4 Dose C 		Candidate E coli vaccine on day 1 and day 180
  • Drug: E coli Vaccine 4 Dose C
    Candidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval
Experimental
E coli Vaccine 5 Dose A
  • Drug: E coli Vaccine 5 Dose A
    Candidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval
Experimental
E coli Vaccine 5 Dose B
  • Drug: E coli Vaccine 5 Dose B
    Candidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval
Experimental
Placebo 		Placebo received on day 1 and day 180
  • Drug: Placebo
    Placebo administered according to a 0, 6-month interval

Recruiting Locations

Anaheim Clinical Trials, LLC
Anaheim, California 92801

Orange County Research Center
Lake Forest, California 92630

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Miami Eye Institute
Hollywood, Florida 33024

Research Centers of America
Hollywood, Florida 33024

NYU Langone Health
New York, New York 10016

CTI Clinical Research Center
Cincinnati, Ohio 45212

Senders Pediatrics
South Euclid, Ohio 44121

Alliance for Multispecialty Research, LLC
Knoxville, Tennessee 37909

Alliance for Multispecialty Research, LLC
Knoxville, Tennessee 37920

University Eye Specialists, P.C. (Ophthalmologist)
Maryville, Tennessee 37803

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com