VAC52416
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March 19, 2025
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
September 08, 2024
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
August 15, 2024
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
June 15, 2024
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
March 27, 2024
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
January 03, 2024
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
November 18, 2023
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
August 23, 2023
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
February 04, 2023
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
October 26, 2022
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
September 08, 2022
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
September 21, 2021
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
April 23, 2021
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
January 20, 2021
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
January 15, 2021
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
January 08, 2021
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
November 24, 2020
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
November 04, 2020
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
June 22, 2020
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
June 22, 2020
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
March 23, 2020
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
March 18, 2020
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
March 12, 2020
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
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