A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults

A Randomized, Double-blind, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Doses of VAC52416 (ExPEC10V) in Japanese Adults Aged 60 to 85 Years

The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (>=) 60 to less than or equal to (<=) 85 years of age.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: ExPEC10V; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 8120025
    • SOUSEIKAI PS Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant must be Japanese as determined by participant's verbal report
• Must be healthy or medically stable, in the investigator's clinical judgment, as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at the screening visit
• Willing and able to adhere to the lifestyle restrictions
• Agrees not to donate blood until 12 weeks after receiving the study intervention
• Must be willing to provide verifiable identification, has means to be contacted, and to contact the investigator during the study

Exclusion Criteria:

• Clinically significant illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4 degree Fahrenheit ) within 24 hours prior to the administration of study intervention; 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
• Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine excipients
• Contraindication to Intramuscular (IM) injections and blood draws example, bleeding disorders

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medium-dose ExPEC10V or Placebo: Group 1; Participants will be randomized to receive a single intramuscular (IM) injection of medium dose of ExPEC10V or Placebo on Day 1.	Biological: ExPEC10V; Participants will receive a single IM injection of ExPEC10V.; Other Names: VAC52416; Biological: Placebo; Participants will receive single IM injection of matching placebo.
Experimental: High-dose ExPEC10V or Placebo: Group 2; Participants will be randomized to receive a single IM injection of high dose (based on safety assessment through Day 15 postvaccination of medium dose) of ExPEC10V or Placebo on Day 1.	Biological: ExPEC10V; Participants will receive a single IM injection of ExPEC10V.; Other Names: VAC52416; Biological: Placebo; Participants will receive single IM injection of matching placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Solicited Local Adverse Events (AEs) Collected for 14 days post-Vaccination	Number of participants with solicited local AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and will be noted in the participant diary for 14 days post-vaccination.	14 days post-Vaccination (Up to Day 15)
Number of Participants with Solicited Systemic AEs Collected for 14 days post-Vaccination	Number of participants with solicited systemic AEs will be reported. Solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.	14 days post-Vaccination (Up to Day 15)
Number of Participants with Unsolicited AEs From the Administration of Study Vaccine until 29 Days post-Vaccination	Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participants diary.	From the administration of study vaccine until 29 days post-Vaccination (Up to Day 30)
Number of Participants with Serious AEs from the Administration of the Study Vaccine until Day 181	Number of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.	From the administration of study vaccine until 180 days post-Vaccination (Up to Day 181)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay	Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.	Days 15 and 30
Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA)	Antibody titers for ExPEC10V will be determined by MOPA.	Day 15 and 30

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): December 24, 2020
• Study Completion (Actual): December 24, 2020

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CR108778; VAC52416BAC1002 (Other Identifier: Janssen Pharmaceutical K.K.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No