The trial is taking place at:
R

Rochester Clinical Research | Rochester, NY

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

J

Janssen (J&J Innovative Medicine)

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Extraintestinal Pathogenic Escherichia Coli Prevention

Treatments

Biological: ExPEC4V
Biological: Prevnar 13
Biological: Placebo
Biological: ExPEC10V

Study type

Interventional

Funder types

Industry

Identifiers

NCT03819049
2020-000657-27 (EudraCT Number)
VAC52416BAC1001 (Other Identifier)
CR108580

Details and patient eligibility

About

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.

Full 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.

Enrollment

836 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

836 participants in 7 patient groups, including a placebo group

Cohort 1: ExPEC10V (Low Dose)
Experimental group
Description:
Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.
Treatment:
Biological: ExPEC10V
Cohort 1: ExPEC10V (Medium dose)
Experimental group
Description:
Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.
Treatment:
Biological: ExPEC10V
Cohort 1: ExPEC10V (High dose)
Experimental group
Description:
Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.
Treatment:
Biological: ExPEC10V
Cohort 1: ExPEC4V
Experimental group
Description:
Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.
Treatment:
Biological: ExPEC4V
Cohort 1: Prevnar 13
Experimental group
Description:
Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.
Treatment:
Biological: Prevnar 13
Cohort 2: ExPEC10V
Experimental group
Description:
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.
Treatment:
Biological: ExPEC10V
Cohort 2: Placebo
Placebo Comparator group
Description:
Participants will be randomized to receive a single IM injection of matching placebo on Day 1.
Treatment:
Biological: Placebo

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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