What side effects are associated with this type of intervention?

The 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) aims to prevent infections by stimulating an immune response against specific O-serotypes of ExPEC. Common side effects of vaccines like ExPEC9V generally include local reactions at the injection site (such as pain, redness, and swelling), mild fever, fatigue, headache, and muscle aches. Serious side effects are rare but can include allergic reactions. It is important to discuss potential side effects with a healthcare provider to understand the risks and benefits of vaccination.

What prior FDA approvals exist?

There is limited specific information available on prior FDA approvals for treatments similar to the 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) for the prevention of Extraintestinal Escherichia Coli Disease. Generally, vaccines that stimulate the immune response to prevent infections by specific O-serotypes of ExPEC are still under study, and ExPEC9V represents a novel approach in this area. Broader preventive measures for E. coli infections have included general hygiene practices, proper food handling, and in some cases, the use of antibiotics for treatment rather than prevention.

What other types of research exist?

Promising alternatives to the 9-valent ExPEC9V vaccine for preventing Extraintestinal Escherichia Coli Disease include: 1) Probiotics, which have been shown to be effective in preventing Clostridium difficile-associated diarrhea and may offer similar benefits for other bacterial infections. 2) Monoclonal antibodies, such as bezlotoxumab, which have been used to prevent recurrent Clostridium difficile infections and could potentially be adapted for use against E. coli. 3) Other vaccines targeting different bacterial pathogens, which may provide cross-protection or be developed specifically for E. coli in the future.

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Cancer Vaccine

ExPEC9V Vaccine for E. coli Infections Prevention

Verified Trial

Phase 3

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and not intending to conceive by any methods

Participant must have a history of UTI in the past 2 years for which evidence of diagnosis was verified by the investigator. In case of a recent history of UTI, the condition must have resolved greater than (>)14 days prior to randomization

Must not have

Participant has end-stage renal disease for which dialysis is required

Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Pivotal Trial

Summary

This trial tests a vaccine to protect older adults from serious E. coli infections. The vaccine trains the immune system to recognize and fight off nine types of harmful E. coli bacteria. In earlier studies, a similar vaccine caused fever and/or diarrhea in some participants and provided limited protection against illness.

Who is the study for?

Adults aged 60+ with a history of UTI in the past 2 years can join this trial. They must be postmenopausal or sterile if born female, not planning to conceive, and able to use digital devices for communication. Excluded are those with bleeding disorders, certain neuropathies, previous E. coli vaccines, or needing dialysis.

What is being tested?

The study tests whether a vaccine called ExPEC9V prevents invasive diseases caused by certain E. coli types better than a placebo in older adults who've had UTIs before.

What are the potential side effects?

Potential side effects may include reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, and possibly allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am postmenopausal or permanently sterile and do not plan to get pregnant.

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I had a urinary tract infection (UTI) in the last 2 years, but it was resolved more than 14 days ago.

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I am postmenopausal, permanently sterile, or not planning to get pregnant.

Select...

I had a UTI in the last 2 years, confirmed by a doctor, and it was resolved more than 14 days ago.

Select...

I am either postmenopausal, permanently sterile, or not planning to get pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I require dialysis for my end-stage kidney disease.

Select...

I have had Guillain-Barre syndrome or a similar nerve condition.

Select...

I have been vaccinated against E. coli or ExPEC.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with First IED Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by ExPEC9V O-serotypes

Number of Participants with First Invasive Extraintestinal Pathogenic E.coli Disease(IED) Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (ExPEC9V) O-serotypes

Secondary study objectives

Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay

Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay

Serotyping

+25 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExPEC9VExperimental Treatment1 Intervention

Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive a single IM injection of matching placebo on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ExPEC9V

2023

Completed Phase 3

~960

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The ExPEC9V vaccine works by stimulating the immune system to produce antibodies against specific O-serotypes of Extraintestinal Pathogenic Escherichia coli (ExPEC), thereby preventing infection. This targeted approach is crucial for patients as it provides protection against the most common and virulent strains of ExPEC, significantly reducing the risk of invasive disease. Other preventive measures include good hygiene practices and the use of probiotics to maintain a healthy gut microbiota, which can help prevent colonization by pathogenic bacteria.