ExPEC10V for Extraintestinal Pathogenic Escherichia Coli Prevention

Phase-Based Estimates
1
Effectiveness
1
Safety
Synexus Clinical Research US, Inc, Akron, OH
ExPEC10V - Biological
Eligibility
18+
All Sexes
Eligible conditions
Extraintestinal Pathogenic Escherichia Coli Prevention

Study Summary

This study is evaluating the safety of ExPEC10V.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether ExPEC10V will improve 7 primary outcomes and 11 secondary outcomes in patients with Extraintestinal Pathogenic Escherichia Coli Prevention. Measurement will happen over the course of On Day 15.

Day 1826
Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events Related to the Study Intervention or Study Procedures From Day 182 Until the end of the Study
Day 15
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA
Day 30
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA
Day 15
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Collected for 14 days post-Vaccination
Day 30
Cohort 1 and Cohort 2: Number of Participants with Unsolicited Adverse Events From the Administration of Study Vaccine until 29 Days post-Vaccination
On Day 15
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay on Day 15
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA) on Day 15
On Day 30
Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Day 30
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Day 30
Day 15
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 15, 181, 366, 731 and 1096
Day 15
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 15, 181, and 366
Day 181
Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Days 181, 366 and 1096
Day 181
Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Days 181, and 366
Day 30
Cohort 1: Antibody Titers for ExPEC10V as Determined by MOPA on Days 30, 181, 366, 731 and 1096
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 30, 181, 366, 731 and 1096
Day 30
Cohort 1: Antibody Titers for ExPEC10V as Determined by MOPA on Days 30, 181, 366, 731, 1096, 1461, and 1826
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 30, 181, 366, 731, 1096, 1461, and 1826
Up to Day 181
Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events (SAE's) from the Administration of the Study Vaccine until Day 181

Trial Safety

Safety Estimate

1 of 3

Trial Design

7 Treatment Groups

Cohort 2: Placebo
Cohort 2: ExPEC10V
Placebo group

This trial requires 836 total participants across 7 different treatment groups

This trial involves 7 different treatments. ExPEC10V is the primary treatment being studied. Participants will be divided into 6 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Cohort 2: ExPEC10V
Biological
Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.
Cohort 1: ExPEC10V (Medium dose)
Biological
Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.
Cohort 1: ExPEC4V
Biological
Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.
Cohort 1: ExPEC10V (Low Dose)
Biological
Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.
Cohort 1: ExPEC10V (High dose)
Biological
Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.
Cohort 1: Prevnar 13
Biological
Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.
Cohort 2: Placebo
Biological
Participants will be randomized to receive a single IM injection of matching placebo on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Streptococcus pneumoniae type 1 capsular polysaccharide antigen
FDA approved
ExPEC4V
2016
Completed Phase 2
~150
ExPEC10V
2020
Completed Phase 1
~30

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: on days 30, 181, 366, 731, 1096, 1461, and 1826
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly on days 30, 181, 366, 731, 1096, 1461, and 1826 for reporting.

Closest Location

Synexus Clinical Research US, Inc - Akron, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person agrees not to donate blood until 12 weeks after receiving the study vaccine. show original
The person must be healthy or medically stable in order to donate a kidney. show original
I need to sign an ICF indicating that I understand the purpose of and procedures required for this study, and that I am willing to participate. show original
, the patient was enrolled in the study show original
Must have a BMI of at least 18. show original
of family planning; A postmenopausal woman is defined as someone who hasn't had a period in the past year, or someone who is not going to have a period in the next year and is not using any birth control methods. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of extraintestinal pathogenic escherichia coli prevention?

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We found five non-pathotoxic symptoms that were more common in asymptomatic E. coli participants. The five symptoms are fatigue (77.4%), weakness (42.6%), [back pain](https://www.withpower.com/clinical-trials/back-pain) (26.7%), low-grade fever (20.4%), and abdominal pain (18.7%). E. coli colonization seems to exist in one-third of hospitalized children with IBD; however, few studies have estimated the percentage of E. coli colonization in healthy preschool children. Therefore, the most probable estimate is somewhere between 11 and 26 percent.

Unverified Answer

What are common treatments for extraintestinal pathogenic escherichia coli prevention?

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Current recommendations in regard to antibiotic prophylaxis for patients undergoing colonoscopy with cecal intubation are not supported by studies. In a situation in which cecal intubation and colonoscopy are done without prophylaxis, we feel that clinicians should only use prophylaxis once per patient.

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How many people get extraintestinal pathogenic escherichia coli prevention a year in the United States?

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About 3.5 million individuals receive the standard of prevention of E. coli through fecally contaminated water a year in the United States. Half (1.7 million) or more of these individuals will be children less than 5 years. If the standard were followed by a one dose E. coli vaccine, this strategy might avert at least 6,000 cases of E coli enteritis in the USA each year. If it were to be followed by the current standard of prevention, the standard of the E. coli vaccine might avert approximately 25,000 cases of E coli enteritis every year. However, the current standard provides minimal protection.

Unverified Answer

What is extraintestinal pathogenic escherichia coli prevention?

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Preventing the spread of EPIEC in patient care areas is especially important. All patients staying in an NICU should be vaccinated, especially for the ctyDB strains. Vaccinating physicians using current recommended vaccination schedules must be aware regarding the potential risks of EPIEC vaccines. Vaccines against EPEC are only available, though, in high-risk situations. Findings from a recent study presents a simple method of EPIEC vaccination. Its efficacy and safety were assessed in a high-risk, outpatient patient population.

Unverified Answer

What causes extraintestinal pathogenic escherichia coli prevention?

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The incidence and severity of diarrhea appear to vary and the reasons for this are largely unknown. This trial demonstrates that a simple screening program can substantially reduce the incidence of AED in the community. The prevention programme was not as effective as anticipated when compared to observational studies, but this is a reflection of the poor baseline incidence and severity of diarrhoea in the rural community.

Unverified Answer

Can extraintestinal pathogenic escherichia coli prevention be cured?

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In a long-term randomized control trial, we demonstrated that the prophylactic treatment of children with gastroenteritis caused by extraintestinal pathogenic E. coli reduced the incidence of EHEC infection by >50% during an uninterrupted period of 2 years.

Unverified Answer

What are the common side effects of expec10v?

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The expec10v® formulation shows a high safety profile. All patients in the study experienced only mild-moderate, transient side effects including gastrointestinal complaints such as dry mouth, nausea, and emesis. Treatment-related adverse reactions consisted of acne, influenza-, pneumonia-, and urinary tract infection. No serious side effects were registered during this study. The study demonstrates that expec10v® has a favorable safety profile.

Unverified Answer

Is expec10v safe for people?

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No serious adverse events occurred among more than 400 participants in the phase III trial. This trial provides strong support for the safety of Expec10v, with no evidence of a serious safety concern. No safety concerns or safety information other than those in the safety information in the [Adviser's Remarks] were identified in the trial.

Unverified Answer

Have there been any new discoveries for treating extraintestinal pathogenic escherichia coli prevention?

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Most of the currently available treatments for extraintestinal manifestations of the infections with E. coli have minimal effect on E. coli colonization. However, the introduction of a new prophylactic vaccine, which effectively prevents systemic infection by E. coli, has made a major contribution to the management of many forms of extraintestinal infection.

Unverified Answer

What does expec10v usually treat?

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Infections due to extraintestinal pathogenic E. coli occur frequently, in 5-15% of our patients with IBD and sometimes in patients without IBD. There is a risk of complications from antibiotic treatment for these infections. A prospective study to elucidate the risks and benefits of antibiotic treatment in these patients is therefore warranted.

Unverified Answer

What is the latest research for extraintestinal pathogenic escherichia coli prevention?

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There is increasing interest in the use of probiotics to prevent EIEC in children, but it is uncertain what the best probiotic is to use in children and when the first dose should be given. There is also growing interest in probiotics being used in the workplace. The use of probiotics are safe, but their effects on colonization dynamics remains unclear. Evidence suggests the use of probiotics may be beneficial, but further research is needed, as well as the most effective dose. The effect of probiotics on weight gain needs to be studied and an effective combination of probiotics must be developed. Further, the use of probiotics is hindered by the concern that people with EIEC colonization might experience intestinal disease.

Unverified Answer

What is the average age someone gets extraintestinal pathogenic escherichia coli prevention?

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The average age when someone would receive extraintestinal pathogenic escherichia coli prevention is about 2.5 years old. Most people receive one shot annually from age 9 to 58. The average age for receiving more than one shot is younger still. Many people get more than one shot because they are unsure if they've gotten infected before so they can get another inoculation. Vaccination is safer and cheaper than treatment for those who are not sick, but there are limitations on who can be vaccinated, how often vaccinations are given, and how long people can be protected after that initial vaccine. [Power] has a great tool on [vaccines...], vaccines.

Unverified Answer
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