NCT03819049

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 836 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Extraintestinal Pathogenic Escherichia Coli Prevention

Interventions

Type	Name	Description
BIOLOGICAL	ExPEC10V	Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.
BIOLOGICAL	ExPEC4V	Participants will receive a single IM injection of ExPEC4V on Day 1.
BIOLOGICAL	Prevnar 13	Participants will receive a single IM injection of Prevnar 13 on Day 1.
BIOLOGICAL	Placebo	Participants will receive single IM injection of matching placebo on Day 1.

Timeline

• Start date: 2019-06-06
• Primary completion: 2021-06-08
• Completion: 2024-12-18
• First posted: 2019-01-28
• Last updated: 2025-05-25
• Results posted: 2024-06-25

Locations

29 sites across 5 countries: United States, Belgium, France, Netherlands, Spain

Regulatory

• FDA-regulated drug study