Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03819049
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2019-01-25
Brief Title:
A Study of Three Different Doses of VAC52416 ExPEC10V in Adults Aged 60 to 85 Years in Stable Health
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Randomized Observer-blind First-in-Human Phase 12a 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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VAC52416BAC1001 | OTHER | None | None |
| 2020-000657-27 | EUDRACT_NUMBER | Janssen Research Development LLC | None |