Clinical trial NCT06134804: A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older
Official title: A Phase 3 Randomized Double-blind Controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of ExPEC9V and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 959
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.


Eligibility criteria: Inclusion Criteria:

* Must be medically stable at the time of vaccination such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy during the 6 weeks before enrollment and when hospitalization for worsening of the disease is not anticipated. Participants will be included on the basis of physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination
* Participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
* Must sign an ICF indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
* Willing and able to adhere to the lifestyle restrictions specified in this protocol
* Agrees to not donate blood from the time of vaccination until 3 months after receiving the last dose of study vaccine

Exclusion Criteria:

* History of an underlying clinically significant acute or uncontrolled chronic medical condition or significant cognitive impairment or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Known or suspected allergy or history of severe allergic reaction, anaphylaxis, or other serious adverse reactions to vaccines or vaccine excipients
* History of severe allergic reactions (for example anaphylaxis) to any component of the high-dose (HD) quadrivalent seasonal influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
* Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the first study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
* History of acute polyneuropathy (for example, Guillain-Barré syndrome) or chronic inflammatory demyelinating polyneuropathy

Primary outcomes:
measure: Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay
timeFrame: 29 days after High-dose (HD) quadrivalent influenza vaccination on Day 1 (Day 30)
measure: Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay 29 days After Administration of ExPEC9V on Day 1
timeFrame: 29 days after administration of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1 (Day 30)
measure: Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay 29 days After Administration of ExPEC9V on Day 30
timeFrame: 29 days after administration of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 30 (Day 59)
Secondary outcomes:
measure: Percentage of Seroconverted Participants
timeFrame: 29 days after HD quadrivalent influenza vaccination on Day 1 (Day 30)
measure: Percentage of Seroprotected Participants
timeFrame: 29 days after HD quadrivalent influenza vaccination on Day 1 (Day 30)
measure: Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Each Vaccination
timeFrame: 14 days post-vaccination 1 on Day 1 (Day 15) and post-vaccination 2 on Day 30 (Day 44)
measure: Percentage of Participants with Solicited Systemic AEs for 14 Days After Each Vaccination
timeFrame: 14 days post-vaccination 1 on Day 1 (Day 15) and post-vaccination 2 on Day 30 (Day 44)
measure: Percentage of Participants with Unsolicited AEs for 29 Days After Each Vaccination
timeFrame: 29 days post-vaccination 1 on Day 1 (Day 30) and post-vaccination 2 on Day 30 (Day 59)
measure: Percentage of Participants with Medically-attended Adverse Events (MAAEs) From Vaccination 1 to Until 6 Months After Vaccination 2
timeFrame: From vaccination 1 (on Day 1) till 6 months after vaccination 2 (on Day 30), that is until Day 210
measure: Percentage of Participants with Serious Adverse Events (SAEs) From Vaccination 1 to Until 6 Months After Vaccination 2
timeFrame: From vaccination 1 (on Day 1) till 6 months after vaccination 2 (on Day 30), that is until Day 210
measure: Antibody Titers to Vaccine O-serotype Antigens and Exotoxin a Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay
timeFrame: At days 1, 30, and 59
measure: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA) 29 Days After Administration of ExPEC9V on Day 1 (Day 30)
timeFrame: 29 days after administration of ExPEC9V on Day 1 (Day 30)
measure: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA) 29 Days After Administration of ExPEC9V on Day 30 (Day 59)
timeFrame: 29 days after administration of ExPEC9V on Day 30 (Day 59)
measure: 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
timeFrame: 29 days after administration of ExPEC9V on Day 1 (Day 30)
measure: 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
timeFrame: 29 days after administration of ExPEC9V on Day 30 (Day 59)
measure: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens as Determined by MOPA 29 days after administration of ExPEC9V on Day 1 (Day 30) in participants with or without History of UTI at Enrollment
timeFrame: 29 days after administration of ExPEC9V on Day 1 (Day 30)
measure: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens as Determined by MOPA 29 days after administration of ExPEC9V on Day 30 (Day 59) in participants with or without History of UTI at Enrollment
timeFrame: 29 days after administration of ExPEC9V on Day 30 (Day 59)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center Inc. (MARC)
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispeciality Research
state: Alabama
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Synexus Clinical Research US Inc
state: Illinois
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Evansville
country: United States
facility: Synexus Radiant Research, Inc
state: Indiana
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, an AMR Company
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispeciality Research
state: Kentucky
city: Creve Coeur
country: United States
facility: Synexus Clinical Research US Inc
state: Missouri
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting Services
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research
state: Ohio
city: East Greenwich
country: United States
facility: Velocity Clinical Research
state: Rhode Island
city: Knoxville
country: United States
facility: Alliance for Multispeciality Research
state: Tennessee
city: Austin
country: United States
facility: Benchmark Clinical Research - Austin
state: Texas
city: Austin
country: United States
facility: Optimal Research
state: Texas
city: Beaumont
country: United States
facility: Tekton Research Inc.
state: Texas
city: Edegem
country: Belgium
facility: Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV)
city: Gent
country: Belgium
facility: Center for Vaccinology (CEVAC)
city: Mechelen
country: Belgium
facility: Az Sint-Maarten
city: Brampton
country: Canada
facility: Aggarwal and associates Ltd
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Levis
country: Canada
facility: Centricity Research- Manna Research (MR) - Quebec Location
state: Quebec
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Gdansk
country: Poland
facility: PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdynia
city: Katowice
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Katowicach
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Lublin
country: Poland
facility: Velocity Lublin
city: Staszow
country: Poland
facility: Velocity Staszow
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Warszawa
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: Synexus Polska Sp z o o Oddzial we Wroclawiu
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development LLC Clinical Trial
role: STUDY_DIRECTOR
References: