A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

NCT ID: NCT03819049

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 836 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2024-12-18

Brief Summary

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.

Detailed Description

ExPEC10V (JNJ-69968054) is a 10-valent vaccine candidate in development for prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease (IED) in adults 60 years of age and older. ExPEC10V consists of O-antigen polysaccharides (PSs) of the ExPEC serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 separately bioconjugate to the carrier protein, a genetically detoxified form of exotoxin A (EPA) derived from Pseudomonas aeruginosa. Since, mechanism of action of conjugate vaccines in prevention of invasive disease is not expected to be affected by antibiotic resistance mechanisms, ExPEC10V vaccine may provide protection against IED caused by drug resistant and susceptible ExPEC serotypes. The study consists of two cohorts. Cohort 1 is comprised of three periods: a screening period (28 days), an observer-blind follow-up period (181 days) with vaccination on Day 1, and an open-label long term follow up (LTFU) period (from Day 182 until 5 years [Day 1826] post-vaccination). Cohort 2 is also comprised of three periods: a screening period (28 days), a double-blind follow-up period (181 days) with vaccination on Day 1, and a double-blind LTFU period (from Day 182 until 1 years [Day 366] post-vaccination). The end of Cohort 1 is considered as the Year 5 visit (Day 1826) for the last participant. The end of Cohort 2 is considered as the Year 1 visit (Day 366) for the last participant. Key immunogenicity assessments will include the assessment of ExPEC10V and ExPEC4V serotype-specific total immunoglobulin G antibody levels elicited by the vaccine and ExPEC10V and ExPEC4V serotype-specific functional antibodies. Key safety assessments include solicited local and systemic AEs, unsolicited AEs, SAEs, physical examinations, vital sign measurements, and, for Cohort 1 only, clinical laboratory tests. The total duration of the study is up to 5 years.

Conditions

Extraintestinal Pathogenic Escherichia Coli Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1: ExPEC10V (Low Dose)

Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.

Group Type: EXPERIMENTAL

ExPEC10V

Intervention Type: BIOLOGICAL

Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.

Cohort 1: ExPEC10V (Medium dose)

Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.

Group Type: EXPERIMENTAL

ExPEC10V

Intervention Type: BIOLOGICAL

Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.

Cohort 1: ExPEC10V (High dose)

Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.

Group Type: EXPERIMENTAL

ExPEC10V

Intervention Type: BIOLOGICAL

Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.

Cohort 1: ExPEC4V

Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.

Group Type: EXPERIMENTAL

ExPEC4V

Intervention Type: BIOLOGICAL

Participants will receive a single IM injection of ExPEC4V on Day 1.

Cohort 1: Prevnar 13

Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.

Group Type: EXPERIMENTAL

Prevnar 13

Intervention Type: BIOLOGICAL

Participants will receive a single IM injection of Prevnar 13 on Day 1.

Cohort 2: ExPEC10V

Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.

Group Type: EXPERIMENTAL

ExPEC10V

Intervention Type: BIOLOGICAL

Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.

Cohort 2: Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

ExPEC10V

Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.

Intervention Type: BIOLOGICAL

ExPEC4V

Participants will receive a single IM injection of ExPEC4V on Day 1.

Intervention Type: BIOLOGICAL

Prevnar 13

Participants will receive a single IM injection of Prevnar 13 on Day 1.

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

Other Intervention Names

VAC52416; JNJ-63871860

Eligibility Criteria

Inclusion Criteria

• Must have a body mass index (BMI) of greater than (>) 18.5 or less than 40 kilogram per meter square (kg/m^2)
• Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods
• Must be healthy or medically stable
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Willing and able to adhere to the lifestyle restrictions specified in this protocol
• Agrees not to donate blood until 12 weeks after receiving the study vaccine

Exclusion Criteria

• Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than equal to >=38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic urinary tract infection (UTI); enrollment at a later date is permitted (provided the screening window of 28 days is respected)
• History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
• Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
• Applicable for Cohort 1 only: known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the active control vaccines)
• Contraindication to intramuscular (IM) injections and blood draws example, bleeding disorders
• Abnormal function of the immune system
• Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12 months

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Optimal Research

Huntsville, Alabama, United States

Optimal Research

Melbourne, Florida, United States

Qps-Mra, Llc

Miami, Florida, United States

Optimal Research

Peoria, Illinois, United States

Synexus Clinical Research US Inc

Evansville, Indiana, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Synexus Clinical Research US Inc

Richfield, Minnesota, United States

Synexus Clinical Research US Inc

Manhattan, New York, United States

Rochester Clinical Research, Inc

Rochester, New York, United States

Synexus Clinical Research US Inc

Akron, Ohio, United States

Synexus Clinical Research US Inc

Columbus, Ohio, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Anima

Alken, , Belgium

ATC Pharma

Liège, , Belgium

Clinical Pharmacology Unit

Merksem, , Belgium

CHU Nantes

Nantes, , France

Hopital Cochin

Paris, , France

APHP - Hopital Bichat - Claude Bernard

Paris, , France

CHU Lyon Sud

Pierre-Bénite, , France

Chu Rennes Hopital Pontchaillou

Rennes, , France

CHRU Tours Hopital Bretonneau

Tours, , France

EB Flevo Research

Almere Stad, , Netherlands

PRA Health Sciences

Groningen, , Netherlands

Hosp. Del Mar

Barcelona, , Spain

Hosp Reina Sofia

Córdoba, , Spain

Hosp. Univ. de La Princesa

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp. Univ. Marques de Valdecilla

Santander, , Spain

Hosp. Virgen Macarena

Seville, , Spain

Countries

United States; Belgium; France; Netherlands; Spain

References

Fierro CA, Sarnecki M, Spiessens B, Go O, Day TA, Davies TA, van den Dobbelsteen G, Poolman J, Abbanat D, Haazen W. A randomized phase 1/2a trial of ExPEC10V vaccine in adults with a history of UTI. NPJ Vaccines. 2024 Jun 14;9(1):106. doi: 10.1038/s41541-024-00885-1.

Reference Type: DERIVED

PMID: 38877036 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VAC52416BAC1001

Identifier Type: OTHER

Identifier Source: secondary_id

2020-000657-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108580

Identifier Type: -

Identifier Source: org_study_id