Rochester Clinical Research | Rochester, NY
A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Status and phase
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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
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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
Allocation
Interventional model
Masking
836 participants in 7 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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