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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

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 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

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

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.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
988 Previous Clinical Trials
6,384,998 Total Patients Enrolled
Janssen Research & Development LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
1 Previous Clinical Trials
18 Total Patients Enrolled
~500 spots leftby Oct 2025