VAC52416 / J&J - LARVOL DELTA

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (clinicaltrials.gov) - P1/2 | N=836 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed

Trial completion

Safety, reactogenicity, and immunogenicity of different doses of 10-valent Extraintestinal Pathogenic Escherichia Coli (ExPEC10V) bioconjugate vaccine (VAC52416) in healthy Japanese adults aged 60 to 85 years in a randomized, double-blind, phase 1 study. (PubMed, J Infect Chemother) - P1 | "ExPEC10V medium- and high-doses were well tolerated with an acceptable safety profile without any significant safety issues in healthy Japanese participants."

Clinical • Journal • P1 data

Engage: A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older (clinicaltrials.gov) - P3 | N=959 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024

Trial completion • Trial completion date • Infectious Disease • Influenza • Respiratory Diseases

A randomized phase 1/2a trial of ExPEC10V vaccine in adults with a history of UTI. (PubMed, NPJ Vaccines) - P1/2 | "ExPEC10V exhibited an acceptable safety profile and a robust vaccine-induced functional immunogenic response in participants with a history of UTI. Clinical trial registration details: https://clinicaltrials.gov/study/NCT03819049 ."

Journal • P1/2 data • Infectious Disease • Nephrology

Engage: A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older (clinicaltrials.gov) - P3 | N=959 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Engage: A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older (clinicaltrials.gov) - P3 | N=932 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Dec 2024 ➔ Feb 2024

Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Engage: A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older (clinicaltrials.gov) - P3 | N=932 | Recruiting | Sponsor: Janssen Research & Development, LLC

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

Safety, Reactogenicity, Immunogenicity, and Dose Selection of 10-Valent Extraintestinal Pathogenic Escherichia coli Bioconjugate Vaccine (VAC52416) in Adults Aged 60-85 Years in a Randomized, Multicenter, Interventional, First-in-Human, Phase 1/2a Study. (PubMed, Open Forum Infect Dis) - P1/2 | "Participants (60-85 years of age) were randomized to ExPEC10V low dose (antigen dose range, 4-8 µg), ExPEC10V medium dose (4-16 µg), or ExPEC10V high dose (8-16 µg); 4-valent ExPEC vaccine (ExPEC4V); or 13-valent pneumococcal conjugate vaccine (PCV13). Based on the totality of data, high-dose ExPEC10V was considered optimal. ExPEC10V was well tolerated and immunogenic in elderly adults against all but serotype O8."

Journal • P1/2 data • Geriatric Disorders • Infectious Disease • Pneumococcal Infections

A phase 1/2a study of the safety, reactogenicity, and immunogenicity of 10-valent ExPEC10V bioconjugate vaccine (VAC52416) in adults with a history of urinary tract infection (ECCMID 2023) - No abstract available

Clinical • P1/2 data • Infectious Disease • Nephrology

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (clinicaltrials.gov) - P1/2 | N=836 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Nov 2023 ➔ Dec 2024

Trial completion date

Safety, Reactogenicity, and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60–85 Years in a Randomized, Multicenter, Interventional, First-In-Human, Phase 1/2a Study (IDWeek 2022) - No abstract available

Clinical • P1/2 data • Infectious Disease

Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escherichia Coli (EXPECT-1) (clinicaltrials.gov) - P=N/A; N=4479; Completed; Sponsor: MJM Bonten; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escherichia Coli (EXPECT-1) (clinicaltrials.gov) - P=N/A; N=4479; Active, not recruiting; Sponsor: MJM Bonten; Trial completion date: Feb 2021 ➔ May 2021

Clinical • Trial completion date • Infectious Disease

A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Janssen Pharmaceutical K.K.; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (clinicaltrials.gov) - P1/2; N=836; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Ten years of population-level genomic Escherichia coli and Klebsiella pneumoniae serotype surveillance informs vaccine development for invasive infections. (PubMed, Clin Infect Dis) - "O-antigen targeted vaccines may be useful in reducing the morbidity, mortality and antimicrobial resistance associated with E. coli and K. pneumoniae BSIs."

Clinical • Journal • Complement-mediated Rare Disorders • Infectious Disease • Pneumonia

A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: Janssen Pharmaceutical K.K.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escherichia Coli (EXPECT-1) (clinicaltrials.gov) - P=N/A; N=4479; Active, not recruiting; Sponsor: MJM Bonten; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (clinicaltrials.gov) - P1/2; N=1004; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial primary completion date: May 2020 ➔ Apr 2021

Clinical • Trial primary completion date

Characterization of Escherichia coli isolates potentially covered by ExPEC4V and ExPEC10V, that were collected from post-transrectal ultrasound-guided prostate needle biopsy invasive urinary tract and bloodstream infections. (PubMed, Vaccine) - "The prevalence of O-serotypes included in a tetravalent ExPEC vaccine was 38.3% by agglutination and 46.7% by PCR, while the prevalence of O-serotypes included in a decavalent vaccine was 58.3% and 73.3%, respectively. Therefore, compared to the tetravalent vaccine, the decavalent vaccine would theoretically provide coverage for serotypes carried by a higher proportion of circulating ExPEC in patients undergoing TRUS-PNB, including a high proportion of antibiotic-resistant organisms."

Journal • Complement-mediated Rare Disorders • PCR

A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Janssen Pharmaceutical K.K.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (clinicaltrials.gov) - P1/2; N=1004; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial completion date: Dec 2022 ➔ Sep 2023

Clinical • Trial completion date

A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Janssen Pharmaceutical K.K.

Clinical • New P1 trial