A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

Janssen Vaccines & Prevention B.V.0 sites1,004 target enrollmentMay 25, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy volunteers (Prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease)
Sponsor: Janssen Vaccines & Prevention B.V.
Enrollment: 1004
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

May 25, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 330

•\- 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