ExPEC9V / J&J, Sanofi - LARVOL DELTA

Formulation Development of a Multivalent Bioconjugate ExPEC Vaccine Candidate: Linking Early Design to Late-Stage Stability and Manufacturability. (PubMed, Vaccines (Basel)) - "The development trajectory of the ExPEC9V vaccine candidate demonstrates that early prioritization of a robust, scalable formulation that remains fit for purpose across valency evolution supports a stable late-stage manufacturable drug product."

Journal

Development and validation of a high-throughput agglutination assay for O-serogrouping clinical Escherichia coli isolates. (PubMed, Microbiol Spectr) - P3 | "Validation was performed in a GCLP-compliant laboratory using clinical isolates representing the nine O-serogroups included in the ExPEC9V vaccine candidate...This study describes the development, optimization, and validation of a high-throughput agglutination O-serotyping assay designed to overcome the constraints of low throughput and operator-dependent variability. The validated assay demonstrated its scientific utility through the characterization of clinical isolates from a Phase 3 trial of a candidate Escherichia coli vaccine.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT04899336."

Journal

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years (clinicaltrials.gov) - P3 | N=19800 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Nov 2027 ➔ Mar 2028

Trial completion date • Infectious Disease • Nephrology

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years (clinicaltrials.gov) - P3 | N=17935 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Nephrology

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years (clinicaltrials.gov) - P3 | N=18556 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: May 2028 ➔ Nov 2027

Trial completion date • Infectious Disease • Nephrology

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years (clinicaltrials.gov) - P3 | N=19800 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2029 ➔ Jul 2027

Trial completion date • Infectious Disease • Nephrology

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years (clinicaltrials.gov) - P3 | N=19800 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2028 ➔ Jun 2029

Trial completion date • Infectious Disease • Nephrology

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years (clinicaltrials.gov) - P3 | N=17935 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Nephrology

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years (clinicaltrials.gov) - P3 | N=19800 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2027 ➔ Aug 2025 | Trial primary completion date: May 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Infectious Disease • Nephrology

Randomised phase III trial of a 9-valent vaccine (ExPEC9V) for prevention of invasive Escherichia coli disease (IED) in older adults (E.mbrace) (ESCMID Global 2026) - No abstract available

Clinical • P3 data

Immunogenicity and Safety of the ExPEC9V Escherichia coli Vaccine Co-Administered with a High-Dose Influenza Vaccine in Older Adults: A Placebo-Controlled, Randomized, Phase 3 Study. (PubMed, Vaccines (Basel)) - P3 | "Co-administration of ExPEC9V with HD influenza vaccine met non-inferiority criteria of humoral immune responses for influenza antigens, but not for ExPEC9V O-serotype antigens. ExPEC9V, administered alone or with HD influenza vaccine, was safe and well tolerated, with an acceptable reactogenicity profile."

Journal • P3 data • Infectious Disease • Influenza • Nephrology • Respiratory Diseases

Variation in sediment and rhizosphere microbial communities of Posidonia oceanica across sites exposed to different human influences. (PubMed, Mar Environ Res) - "By contrast, bacterial communities in the P. oceanica rhizosphere did not vary among sites exposed to different human pressures and were enriched with Acidimicrobiia (i.e., Ilumatobacter fluminis and CADEDH01 sp902826025) in respect to surrounding sediments...However, an inability for root bacterial communities to adapt to changes in environmental conditions may render them vulnerable to increasing environmental stress. Testing these two contrasting hypotheses will be an important avenue for future research."

Journal

Extraintestinal pathogenic Escherichia coli (ExPEC) O-serotype distribution and antibiotic resistance profiles among the aging population in China: A longitudinal, multi-center study. (PubMed, Int J Antimicrob Agents) - "In conclusion, O25 is the most prevalent O serotype among ExPEC isolates. The ExPEC9V O-serotype prevalence is generally consistent across MDR and different sexes."

Journal • Infectious Disease • Septic Shock

Population structure of Escherichia coli isolated from the human bloodstream, human and animal feces, and the environment in northern Tanzania. (PubMed, J Infect Dis) - "We found a high diversity of sequence types among E. coli human bloodstream isolates in Tanzania. Despite this diversity, we observed that an EXPEC9V in development would provide good coverage. Reservoir attribution studies at finer spatial and temporal scales may better identify transmission networks and reservoirs of ExPECs."

Journal • Infectious Disease

High diversity of Escherichia coli causing invasive disease in neonates in Malawi poses challenges for O-antigen based vaccine approach. (PubMed, Commun Med (Lond)) - "Vaccines against neonatal sepsis in Africa are of considerable potential value, but their development requires larger studies to establish the diversity and stability over time of relevant O-types for this population."

Journal • Infectious Disease • Septic Shock

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 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

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