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Recruiting NCT07122986

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

Phase I Interventional Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: E coli vaccine 1 Dose A, E coli vaccine 1 Dose B, E coli vaccine 2, E coli vaccine 3.
Who it may be relevant to
Registry conditions: Healthy Participants. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug E coli vaccine 1 Dose A
    Candidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval
  • Drug E coli vaccine 1 Dose B
    Candidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval
  • Drug E coli vaccine 2
    Candidate E coli vaccine 2, administered according to a 0, 6-month interval
  • Drug E coli vaccine 3
    Candidate E coli vaccine 3, administered according to a 0, 6-month interval
  • Drug E coli Vaccine 4 Dose A
    Candidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval
  • Drug E coli Vaccine 4 Dose B
    Candidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval
  • Drug E coli Vaccine 4 Dose C
    Candidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval
  • Drug E coli Vaccine 5 Dose A
    Candidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval
  • Drug E coli Vaccine 5 Dose B
    Candidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval
  • Drug Placebo
    Placebo administered according to a 0, 6-month interval

Primary outcome measures

  • Percentage of participants reporting prespecified local events within 7 days following each vaccination [Time frame: 7 days after each vaccination]
  • Percentage of participants reporting prespecified systemic events within 7 days following each vaccination [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline up to month 18 with final visit being 12 months after last assigned vaccination]

Eligibility criteria

Ages Eligible for Study: 18 to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 11 centers
  • Anaheim Clinical Trials, LLC — Anaheim
  • Orange County Research Center — Lake Forest
  • Diablo Clinical Research, Inc. — Walnut Creek
  • Miami Eye Institute — Hollywood
  • Research Centers of America — Hollywood
  • NYU Langone Health — New York
  • CTI Clinical Research Center — Cincinnati
  • Senders Pediatrics — South Euclid
  • … and 3 more centers

Identifiers

NCT: NCT07122986 · C5211001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗