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

Pfizer

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: E coli Vaccine 4 Dose C; Drug: E coli vaccine 3; Drug: E coli vaccine 2; Drug: E coli Vaccine 4 Dose A; Drug: E coli Vaccine 4 Dose B; Drug: E coli vaccine 1 Dose B; Drug: Placebo; Drug: E coli vaccine 1 Dose A; Drug: E coli Vaccine 5 Dose B; Drug: E coli Vaccine 5 Dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07122986

C5211001

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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310 participants in 10 patient groups

E coli vaccine 1 Dose A

Experimental group

Description:

Candidate E coli vaccine on day 1 and day 180

Treatment:

Drug: E coli vaccine 1 Dose A

E coli vaccine 1 Dose B

Experimental group

Description:

Candidate E coli vaccine on day 1 and day 180

Treatment:

Drug: E coli vaccine 1 Dose B

E coli vaccine 2

Experimental group

Description:

Candidate E coli vaccine on day 1 and day 180

Treatment:

Drug: E coli vaccine 2

E coli vaccine 3

Experimental group

Description:

Candidate E coli vaccine on day 1 and day 180

Treatment:

Drug: E coli vaccine 3

E coli Vaccine 4 Dose A

Experimental group

Description:

Candidate E coli vaccine on day 1 and day 180

Treatment:

Drug: E coli Vaccine 4 Dose A

E coli Vaccine 4 Dose B

Experimental group

Description:

Candidate E coli vaccine on day 1 and day 180

Treatment:

Drug: E coli Vaccine 4 Dose B

E coli Vaccine 4 Dose C

Experimental group

Description:

Candidate E coli vaccine on day 1 and day 180

Treatment:

Drug: E coli Vaccine 4 Dose C

E coli Vaccine 5 Dose A

Experimental group

Treatment:

Drug: E coli Vaccine 5 Dose A

E coli Vaccine 5 Dose B

Experimental group

Treatment:

Drug: E coli Vaccine 5 Dose B

Placebo

Experimental group

Description:

Placebo received on day 1 and day 180

Treatment:

Drug: Placebo