E Coli Vaccine for Healthy Adults

Recruiting at 8 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Severe allergies, Immunodeficiency, Pregnancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine designed to protect healthy adults from Escherichia coli (E. coli) infections. The main goal is to determine the vaccine's safety and tolerability. Participants will receive varying doses of the vaccine or a placebo (a harmless substance with no therapeutic effect) for comparison. Ideal candidates are healthy adults without a history of severe allergic reactions to vaccines. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the E. coli vaccine is generally well-tolerated in humans. In one study, 29% of participants reported mild reactions, such as pain at the injection site. About 43% experienced mild reactions like fatigue or headache. These reactions were temporary and resolved on their own. Another research update found no serious safety concerns with the vaccine. These findings suggest the vaccine is safe for healthy adults, though further studies are needed to confirm these results.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Unlike the standard of care for preventing E. coli infections, which mainly involves hygiene practices and antibiotics, this new E. coli vaccine represents a proactive approach to immunization. Researchers are excited about this treatment because it aims to provide long-lasting protection against E. coli by directly targeting the bacteria, potentially reducing the need for antibiotics and the risk of antibiotic resistance. Furthermore, the vaccine is designed to be administered in a straightforward two-dose schedule, possibly enhancing compliance and effectiveness.

What evidence suggests that this trial's E coli vaccines could be effective for healthy adults?

Research has shown that E. coli vaccines may help reduce the number and severity of infections caused by ETEC, a type of E. coli. One study found that a similar vaccine was safe and successfully triggered long-lasting immune responses. Another study showed that the vaccine was well-tolerated and produced strong immune reactions in early tests. However, vaccines for other E. coli strains have not been effective enough in preventing serious illness. This trial will test various versions of the E. coli vaccine, each in different treatment arms, to evaluate their safety and effectiveness. Overall, these findings suggest that the vaccine could potentially protect against E. coli infections, but more research is needed to confirm its effectiveness for this new version.² ⁴ ⁵ ⁶ ⁷

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to evaluate the safety of various doses and combinations of an investigational E. coli vaccine. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Healthy participants as determined by medical history, physical examination, and clinical judgement of the investigator to be eligible for inclusion in the study.

I am between 18 and 63 years old.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the E coli vaccine or placebo on day 1 and day 180

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Final visit 12 months after last vaccination

What Are the Treatments Tested in This Trial?

Interventions

E coli Vaccine

Trial Overview The study is testing multiple vaccines against E. coli, with different doses and combinations given intramuscularly to see how well they're tolerated and if they're safe. Some participants will receive a placebo instead of the actual vaccine.

How Is the Trial Designed?

10Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Placebo received on day 1 and day 180

Group II: E coli vaccine 3Experimental Treatment1 Intervention