ExPEC-4V / J&J, GSK - 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

A microbiological and genomic perspective of globally collected Escherichia coli from adults hospitalized with invasive E. coli disease. (PubMed, J Antimicrob Chemother) - "Our results highlight the predominance of MDR O25b-ST131 E. coli isolates across diverse geographic areas. These findings provide further baseline data on the theoretical coverage of novel vaccines targeting E. coli associated with IED in older adults and their associated AMR levels."

Journal • Infectious Disease • Septic Shock

Advances in Bacterial Lysate Immunotherapy for Infectious Diseases and Cancer. (PubMed, J Immunol Res) - "Moreover, OM-89, Uromune, Urovac, Urivac, and ExPEC4V showed therapeutic benefits in controlling urinary tract infections in adults, especially women. Later, several similar bacterial lysate-based therapeutics have been developed to treat cancers, including bladder cancer, non-small cell lung cancer, and myeloma; among them, BCG for in situ bladder cancer is well-known. Proinflammatory cytokines, including IL-1, IL-6, IL-12, and TNF-α, may activate bacterial antigen-specific adaptive responses that could restore tumor antigen recognition and response by tumor-specific type 1 helper cells and cytotoxic T cells; therefore, bacterial lysates are worth investigating as a vaccination adjuvants or add-on therapies for several cancers."

Journal • Review • Bladder Cancer • Chronic Obstructive Pulmonary Disease • Genito-urinary Cancer • Hematological Malignancies • Immunology • Infectious Disease • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Nephrology • Non Small Cell Lung Cancer • Oncology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sarcoma • Sinusitis • Solid Tumor • IL12A • IL6 • TNFA

Bacterial Vaccines for the Management of Recurrent Urinary Tract Infections: A Systematic Review and Meta-analysis. (PubMed, Eur Urol Focus) - "There is limited evidence to suggest that vaccinations are effective at reducing UTI recurrence in adult female patients in the short term. Owing to low quality of evidence, the literature requires further long-term RCTs with large sample sizes utilising standardised definitions for conclusive evidence of the long-term efficacy of vaccination in rUTI prevention."

Journal • Retrospective data • Review • Infectious Disease • Nephrology

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 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

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

Extraintestinal pathogenic Escherichia coli surveillance study to determine O-serotype prevalence and antibiotic resistance in blood isolates collected in Europe, 2011–2017 (ECCMID 2019) - "Very few recent studies describe ExPEC O-serotypes associated with IED. We identified the most common O-serotypes responsible for the majority of bloodstream infections in Europe. Supported by these findings, a 10-valent ExPEC vaccine against IED is currently in development."

Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Nephrology • Septic Shock

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

Safety and immunogenicity of a vaccine for extra-intestinal pathogenic Escherichia coli (ESTELLA): a phase 2 randomised controlled trial. (PubMed, Lancet Infect Dis) - P2 | "EXPEC4V seemed well tolerated and elicited robust and functional antibody responses across all serotypes, doses, and age groups. For the two dosages evaluated (4:4:4:8 μg and 8:8:8:16 μg), the immune response persisted for 1 year."

Clinical • Journal • P2 data • Fatigue • Pain

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 in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860 (clinicaltrials.gov) - P2; N=848; Completed; Sponsor: Janssen Research & Development, LLC; 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=1004; Recruiting; Sponsor: Janssen Research & Development, LLC; N=404 ➔ 1004

Clinical • Enrollment change

Safety and Immunogenicity of two Doses of ExPEC4V Vaccine Against Extraintestinal Pathogenic Escherichia coli Disease in Healthy Adult Participants (IDWeek 2019) - "Good correlation was observed between ELISA and OPA across serotypes (r≥ 0.76).Conclusion : ExPEC4V elicited robust and functional immune responses across all serotypes and was well tolerated with no vaccine safety findings. This study supports the development of future multivalent ExPEC vaccine to prevent IED."

Clinical

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (clinicaltrials.gov) - P1/2; N=404; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial primary completion date: Jul 2019 ➔ May 2020

Clinical • Trial primary completion date

A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860 (clinicaltrials.gov) - P2; N=848; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Trial completion date: Aug 2020 ➔ Sep 2019

Clinical • Trial completion date

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (clinicaltrials.gov) - P1/2; N=404; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older (clinicaltrials.gov) - P2; N=108; Completed; Sponsor: Janssen Research & Development, LLC; 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=404; Not yet recruiting; Sponsor: Janssen Research & Development, LLC; Trial completion date: May 2022 ➔ Oct 2022

Clinical • Trial completion date

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (clinicaltrials.gov) - P1/2; N=400; Not yet recruiting; Sponsor: Janssen Research & Development, LLC; Trial primary completion date: May 2022 ➔ Jul 2019

Clinical • Trial primary completion date

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (clinicaltrials.gov) - P1/2; N=400; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1/2 trial