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

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.

Start Date06 Jun 2019

Sponsor / Collaborator

Janssen Research & Development LLC

NCT03500679

/ CompletedPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Immunogenicity of the ExPEC4V (JNJ-63871860) Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Subjects Aged 18 Years and Older

The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).

Start Date09 May 2018

Sponsor / Collaborator

Janssen Research & Development LLC

NCT02748967

/ CompletedPhase 1

Randomized, Double-Blind, Placebo-controlled Phase 1 Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860

The purpose of this study is to assess the safety and tolerability of different doses of ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20 years of age.

Start Date01 Apr 2016

Sponsor / Collaborator

Janssen Pharmaceuticals, Inc.

100 Clinical Results associated with E coli bioconjugate vaccine(GlaxoSmithKline Plc)

100 Translational Medicine associated with E coli bioconjugate vaccine(GlaxoSmithKline Plc)

100 Patents (Medical) associated with E coli bioconjugate vaccine(GlaxoSmithKline Plc)

Literatures (Medical) associated with E coli bioconjugate vaccine(GlaxoSmithKline Plc)

03 Sep 2024·Journal of Antimicrobial Chemotherapy

A microbiological and genomic perspective of globally collected Escherichia coli from adults hospitalized with invasive E. coli disease

Article

Author: Morrow, Brian ; Walker, Sarah V. ; Salerno, Nicola Duccio ; Violette, Madison ; Nuin, Enya Arconada ; Poolman, Jan ; Spiessens, Bart ; De Blacam, Killian ; Barraud, Olivier ; Righi, Elda ; Van Puyvelde, Sandra ; Van Mieghem, Sofie ; Goossens, Herman ; Vilken, Tuba ; Thaden, Joshua ; Xavier, Basil Britto ; Lo Cascio, Giuliana ; Munshi, Sonal ; Doua, Joachim ; Akai, Naomi ; Kimura, Risa ; Go, Oscar ; Espindola, Reinaldo ; Cremonini, Eleonora ; Lammens, Christine ; Geurtsen, Jeroen ; Ekkelenkamp, Miquel ; Dagher, Michael ; Pascual, Alvaro ; Aitabi, Moussa ; Bonten, Marc ; Azzini, Anna Maria ; Palomo, Virginia ; Ruffin, Felicia ; Leten, Gert ; Glupczynski, Youri ; Lakatos, Louis ; Sarnecki, Michal

AbstractObjectivesEscherichia coli can cause infections in the urinary tract and in normally sterile body sites leading to invasive E. coli disease (IED), including bacteraemia and sepsis, with older populations at increased risk. We aimed to estimate the theoretical coverage rate by the ExPEC4V and 9V vaccine candidates. In addition, we aimed at better understanding the diversity of E. coli isolates, including their genetic and phenotypic antimicrobial resistance (AMR), sequence types (STs), O-serotypes and the bacterial population structure.MethodsBlood and urine culture E. coli isolates (n = 304) were collected from hospitalized patients ≥60 years (n = 238) with IED during a multicentric, observational study across three continents. All isolates were tested for antimicrobial susceptibility, O-serotyped, whole-genome sequenced and bioinformatically analysed.ResultsA large diversity of STs and of O-serotypes were identified across all centres, with O25b-ST131, O6-ST73 and O1-ST95 being the most prevalent types. A total of 45.4% and 64.7% of all isolates were found to have an O-serotype covered by the ExPEC4V and ExPEC9V vaccine candidates, respectively. The overall frequency of MDR was 37.4% and ST131 was predominant among MDR isolates. Low in-patient genetic variability was observed in cases where multiple isolates were collected from the same patient.ConclusionsOur 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.

01 Jan 2024·Journal of Immunology Research

Advances in Bacterial Lysate Immunotherapy for Infectious Diseases and Cancer

Review

Author: Wei, Ming Q. ; Ulett, Glen C. ; Grice, I. Darren ; Rahman, Md. Mijanur

Antigenic cell fragments, pathogen‐associated molecular patterns, and other immunostimulants in bacterial lysates or extracts may induce local and systemic immune responses in specific and nonspecific paradigms. Based on current knowledge, this review aimed to determine whether bacterial lysate has comparable functions in infectious diseases and cancer treatment. In infectious diseases, including respiratory and urinary tract infections, immune system activation by bacterial lysate can identify and combat pathogens. Commercially available bacterial lysates, including OM‐85, Ismigen, Lantigen B, and LW 50020, were effective in children and adults in treating respiratory tract infections, chronic obstructive pulmonary disease, rhinitis, and rhinosinusitis with varying degrees of success. Moreover, OM‐89, Uromune, Urovac, Urivac, and ExPEC4V showed therapeutic benefits in controlling urinary tract infections in adults, especially women. Bacterial lysate‐based therapeutics are safe, well‐tolerated, and have few side effects, making them a good alternative for infectious disease management. Furthermore, a nonspecific immunomodulation by bacterial lysates may stimulate innate immunity, benefiting cancer treatment. “Coley’s vaccine” has been used to treat sarcomas, carcinomas, lymphomas, melanomas, and myelomas with varying outcomes. 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.

01 May 2020·European Urology FocusQ2 · MEDICINE

Role of Vaccines for Recurrent Urinary Tract Infections: A Systematic Review

Q2 · MEDICINE

Review

Author: Somani, Bhaskar K ; Prattley, Sarah ; Geraghty, Robert ; Moore, Michael

CONTEXTRecurrent urinary tract infections (rUTIs) can be a difficult condition to treat, and the role of vaccines is unclear.OBJECTIVETo systematically review the role of vaccines in the treatment of rUTIs, looking at efficacy, adverse events, and discontinuation from treatment.EVIDENCE ACQUISITIONWe systematically reviewed the role of vaccines for rUTIs using the Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) methodologies for all English-language articles from inception of databases to July 2018. Data were collected for different vaccine types, short- (≤6 mo) and long-term (>6 mo) efficacy, and adverse effects with risk of bias assessment of included studies.EVIDENCE SYNTHESISAfter initial identification of 1680 articles, 36 abstracts were screened, 25 full-text articles were assessed, and 17 (including 3228 patients; 1970 in the vaccine group and 1258 in the comparison group) were included. There were three studies in Uromune, nine in OM-89/UroVaxom, four in Solco-Urovac, and one in ExPEC4 V groups. Uromune, UroVaxom, and Solco-Urovac reported on the short-term follow-up, and the overall efficacy for vaccination demonstrated a significant odds ratio (OR) of 0.17 (95% confidence interval [CI] 0.06-0.50). Uromune, UroVaxom, and ExPEC4 V reported on the long-term follow-up, and the overall efficacy for vaccination demonstrated a significant OR of 0.20 (95% CI 0.07-0.59). The reported side effects were mild and varied from 0% to 13% across studies, and treatment withdrawal or exclusion due to adverse events was reported in 11 patients.CONCLUSIONSVaccines seem to have a short-term role in the prevention of recurrent urinary tract infections with tolerable side effects. However, due to lack of uniformity of definitions and long-term follow-up, more work needs to be done with inclusion of other high-risk patient groups.PATIENT SUMMARYIn this study, we look at the role of vaccines for recurrent urinary tract infections. We found that they seem to have a short-term role in the prevention of recurrent urinary tract infections and might play an increasing role in the future.

100 Deals associated with E coli bioconjugate vaccine(GlaxoSmithKline Plc)

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Indication	Highest Phase	Country/Location	Organization	Date
Urinary Tract Infections	Phase 2	-	Janssen Global Services LLC	-
Urinary Tract Infections	Phase 2	-	GSK Plc	-
Escherichia Coli Infections	Preclinical	United States	Janssen Pharmaceuticals, Inc.	23 Nov 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03500679 (CTgov)	Phase 2	-	100	ExPEC4V vaccine (ExPEC4V)	vobyjqcaww(ekgpeamfkm) = egrrhiffto uubijwnnth (pdjwxujxhq, blckvmrdjo - oilvvovjie) View more	-	26 Nov 2019
				placebo+ExPEC4V (Placebo)	vobyjqcaww(ekgpeamfkm) = ndhzujpsyo uubijwnnth (pdjwxujxhq, oyhqnfvsir - ozhptlsgrb) View more
NCT02546960 (ESTELLA, Pubmed \| Lancet Infect Dis) Manual	Phase 2	-	843	JNJ-63871860	(nnflvnfzav) = xyqluttogy ewhreefzvr (zzhadphewj ) View more	Positive	01 Jun 2019
				Placebo	(nnflvnfzav) = qlfepwydid ewhreefzvr (zzhadphewj ) View more

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