A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Immunogenicity of the ExPEC4V (JNJ-63871860) Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Subjects Aged 18 Years and Older

The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: ExPEC4V; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Heartland Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • VGR & NOCCR - Knoxville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants who provides written informed consent and signs the informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
• Participant is medically stable as confirmed by documented medical history, physical examination and vital signs. Participant may have underlying illnesses such as hypertension, diabetes, or ischemic heart disease, as long as their symptoms/signs are medically controlled. If he/she is on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination
• Participant must have a body mass index (BMI) of less than or equal to (<=)35.0 kilogram per square meter (kg/m^2)
• Contraceptive (birth control) use by woman should be consistent with local regulations regarding the acceptable methods of contraception for participant participating in clinical studies
• All females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at pregnancy test on Visit 1 (pre-vaccination) and Visit 4 (prior to the second vaccination)

Exclusion Criteria:

• Participant with contraindication to intramuscular (IM) injections and blood draws, for example, bleeding disorders
• Participant with known allergies, hypersensitivity, or intolerance to ExPEC4V or its excipients
• Participant with abnormal function of the immune system resulting from: a) clinical conditions (for example, autoimmune disease or immunodeficiency); b) chronic or recurrent use of systemic corticosteroids; c) administration of antineoplastic and immunomodulating agents or radiotherapy
• Participant has a history of neoplastic disease (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated) within the past 1 year or a history of any hematological malignancy
• Participant with history of acute polyneuropathy (for example, Guillain-Barre syndrome)
• Participant who has a history of an underlying clinically significant acute or (uncontrolled) chronic medical condition 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: ExPEC4V (JNJ-63871860); Participants will receive vaccination of ExPEC4V dose as an intramuscular (IM) injection into deltoid muscle on Days 1 and 181. The ExPEC4V doses contain polysaccharide antigen (4:4:4:8 microgram [mcg]) from the ExPEC4V serotypes O1A, O2, O6A, and O25B.	Biological: ExPEC4V; Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181.; Other Names: JNJ-63871860
Placebo Comparator: Group 2: Placebo; Participants will receive placebo matching to ExPEC4V as an IM injection on Days 1 and 181.	Biological: Placebo; Participants will receive placebo as an IM injection on Days 1 and 181.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.	14 days after first vaccination (Day 1 to Day 15)
Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.	14 days after first vaccination (Day 1 to Day 15)
Percentage of Participants With Unsolicited Adverse Events After First Vaccination	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.	29 days after first vaccination (Day 1 to Day 30)
Number of Participants With Serious Adverse Events (SAEs) After First Vaccination	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.	Up to Day 180
Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1	Immunoglobulin G (IgG) antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 1 were reported.	Day 1
ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15	IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 15 were reported.	Day 15
ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1	IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.	Day 15/Day 1
Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15	Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Day 15 were reported.	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Solicited Local Adverse Events After Second Vaccination	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.	14 days after second vaccination (Day 181 to Day 195)
Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.	14 days after second vaccination (Day 181 to Day 195)
Percentage of Participants With Unsolicited Adverse Events After Second Vaccination	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.	29 days after second vaccination (Day 181 to Day 210)
Number of Participants With Serious Adverse Events After Second Vaccination	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.	Day 181 until Day 360
Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15	Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 1 and 15 were reported.	Days 1 and 15
OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1	Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.	Day 15/Day 1
Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15	Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Day 15 were reported.	Day 15
ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195	IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A, O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.	Days 181 and 195
ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1	IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 181/Day 1 and Day 195/Day 1) was reported.	Day 181/Day 1 and Day 195/Day 1
Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195	Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Days 181 and 195 were reported.	Days 181 and 195
OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195	Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.	Days 181 and 195
OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1	Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 were reported.	Day 181/Day 1 and Day 195/Day 1
Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195	Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Days 181 and 195 were reported.	Days 181 and 195

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2018
• Primary Completion (Actual): November 5, 2018
• Study Completion (Actual): June 11, 2019

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CR108447; 63871860BAC2003 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No