What side effects are associated with this type of intervention?

Common side effects of vaccines for Extraintestinal Escherichia Coli Disease Prevention, similar to the 9-valent Extraintestinal Pathogenic Escherichia coli Vaccine and the High-Dose Quadrivalent Seasonal Influenza Vaccine, include local reactions at the injection site (pain, redness, swelling), systemic reactions (fever, fatigue, muscle aches), and, less commonly, allergic reactions. Severe adverse effects, such as anaphylaxis, are rare.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved vaccines for the prevention of Extraintestinal Pathogenic Escherichia coli (ExPEC) infections similar to the 9-valent ExPEC vaccine being studied. Current research is focused on developing vaccines that target multiple O-serotype antigens of E. coli to provide broad protection. The High-Dose Quadrivalent Seasonal Influenza Vaccine, which induces an immune response against four influenza strains, serves as a model for the type of immune response researchers aim to achieve with the ExPEC vaccines. Broadly, the development of such vaccines is in the experimental stage, with ongoing trials assessing their safety and immunogenicity.

What other types of research exist?

Promising novel alternatives for preventing Extraintestinal Escherichia coli Disease in 2024 include vaccines targeting conserved proteins across E. coli strains, such as the Shigella type III secretion system proteins IpaB and IpaD, which have shown high immunogenicity. Additionally, advancements in mucosal vaccines and the use of adjuvants like dmLT to enhance immune responses are also promising. These approaches aim to provide broad protection and could be effective alternatives to the current vaccines.

← Back to Search

Cancer Vaccine

ExPEC9V + High-Dose Flu Vaccine for E. coli and Influenza Prevention (Engage Trial)

Phase 3

Waitlist Available

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

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 29 days post-vaccination 1 on day 1 (day 30) and post-vaccination 2 on day 30 (day 59)

Awards & highlights

Pivotal Trial

Summary

This trial is testing if a high-dose flu shot and an E. coli vaccine can be given together without reducing their effectiveness. It targets people who need both vaccines, ensuring that the immune system can still recognize and fight off both flu viruses and E. coli bacteria.

Who is the study for?

This trial is for adults aged 65 or older who are medically stable, understand the study's risks and benefits, agree not to donate blood during the study period, and women must be postmenopausal. Participants should not expect hospitalization soon and must follow lifestyle restrictions.

What is being tested?

The study tests if a high-dose flu vaccine (HD QIV) affects antibody response when given with a new E. coli vaccine (ExPEC9V), compared to each vaccine given alone in seniors.

What are the potential side effects?

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 29 days post-vaccination 1 on day 1 (day 30) and post-vaccination 2 on day 30 (day 59)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~29 days post-vaccination 1 on day 1 (day 30) and post-vaccination 2 on day 30 (day 59)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 29 days post-vaccination 1 on day 1 (day 30) and post-vaccination 2 on day 30 (day 59) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay 29 days After Administration of ExPEC9V on Day 1

Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay 29 days After Administration of ExPEC9V on Day 30

Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay

Secondary study objectives

Antibody Titers to Vaccine O-serotype Antigens and 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 ECL-based Immunoassay 29 days after administration of ExPEC9V on Day 1 (Day 30) in participants with or without History of Urinary Tract Infection (UTI) at Enrollment

Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex ECL-based Immunoassay 29 days after administration of ExPEC9V on Day 30 (Day 59) in participants with or without History of Urinary Tract Infection (UTI) at Enrollment

+11 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

Group I: Group 2: Control GroupExperimental Treatment3 Interventions

Participants will receive IM injection of matching placebo along with HD quadrivalent influenza vaccine, concomitantly, on Day 1 and ExPEC9V on Day 30.

Group II: Group 1: Coadministration (CoAd) GroupExperimental Treatment3 Interventions

Participants will receive intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) along with high-dose (HD) quadrivalent influenza vaccine, concomitantly, on Day 1 and placebo on Day 30.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ExPEC9V

2023

Completed Phase 3

~960

Placebo

1995

Completed Phase 3

~2670

HD quadrivalent influenza vaccine

2023

Completed Phase 3

~960

Do I qualify?Apply below to find out

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 most common treatments for Extraintestinal Escherichia Coli (ExPEC) Disease Prevention involve vaccines that stimulate the immune system to recognize and combat specific pathogens. The High-Dose Quadrivalent Seasonal Influenza Vaccine (HD QIV) induces an immune response against four influenza strains, while the 9-Valent Extraintestinal Pathogenic Escherichia coli Vaccine (ExPEC9V) targets nine O-serotype antigens of E. coli. These vaccines are essential for ExPEC Disease Prevention patients as they help reduce the incidence of infections, thereby decreasing morbidity and mortality associated with these pathogens.

Ten Years of Population-Level Genomic Escherichia coli and Klebsiella pneumoniae Serotype Surveillance Informs Vaccine Development for Invasive Infections.Impact of enrofloxacin and florfenicol therapy on the spread of OqxAB gene and intestinal microbiota in chickens.Development of safe, effective and immunogenic vaccine candidate for diarrheagenic Escherichia coli main pathotypes in a mouse model.