CLINICAL TRIAL

strain CVD 1208S-122 for Escherichia coli Infections

Waitlist Available · 18 - 65 · All Sexes · Baltimore, MD

This study is evaluating whether a live, oral, combined Shigella-ETEC vaccine candidate is safe and immunogenic.

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About the trial for Escherichia coli Infections

Eligible Conditions
Communicable Diseases · Dysentery, Bacillary · Shigella Infection · Escherichia coli Infections · Infections · Enterotoxigenic Escherichia Coli Infection

Treatment Groups

This trial involves 4 different treatments. Strain CVD 1208S-122 is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Placebo
OTHER
+
strain CVD 1208S-122
BIOLOGICAL
Experimental Group 2
Placebo
OTHER
+
strain CVD 1208S-122
BIOLOGICAL
Experimental Group 3
Placebo
OTHER
+
strain CVD 1208S-122
BIOLOGICAL
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Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or female, 18 - 49 years of age
Written informed consent provided
Determined to be in good health* based on medical history and review of concomitant medications
*Good health as defined by an absence of an active chronic medical condition which requires daily prescription medication(s). Participants may be eligible if the medical condition only requires infrequent as needed (PRN) medication and if the investigator determines that the condition does not pose a risk to participant safety or the assessment of reactogenicity and immunogenicity. Any chronic medical condition which does not require a daily prescription medication but might pose a risk to a participant with rapid dehydration (i.e., rapid intravascular volume changes) would be ineligible to participate.
Complete blood count (CBC) with differential for total white blood cell count (WBC), absolute neutrophil count (ANC), hemoglobin (Hg), platelet count
Creatinine, alanine aminotransferase (ALT), total bilirubin
Serum Immunoglobulin A (IgA) level
Human immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV)
HLA-B27 histocompatibility testing
Serum Beta human chorionic gonadotropin (β-HCG) test, if the participant is a woman of child-bearing potential
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: The entire study period (6-7 months)
Screening: ~3 weeks
Treatment: Varies
Reporting: The entire study period (6-7 months)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: The entire study period (6-7 months).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether strain CVD 1208S-122 will improve 8 primary outcomes in patients with Escherichia coli Infections. Measurement will happen over the course of for each day of the 7 days following vaccination.

Number and Proportion of Sequential Days of Fecal Shedding of Shigella Organisms
FOR EACH DAY OF THE 7 DAYS FOLLOWING VACCINATION
The number and proportion of sequential days of fecal shedding of Shigella organisms which are documented to contain the genes expressing ETEC antigens for each dosage group. Genetically stable organisms will be defined as being PCR positive for Shigella (ipaH or virG), CFA/I (cfaB), and LTB (eltB)
FOR EACH DAY OF THE 7 DAYS FOLLOWING VACCINATION
Geometric Mean Number of Vaccine Organisms
FOR EACH DAY OF THE 7 DAYS FOLLOWING VACCINATION
The geometric mean number (and interquartile range) of vaccine organisms, per day and at the peak of shedding, expressed as cfu/mL for each dosage group
FOR EACH DAY OF THE 7 DAYS FOLLOWING VACCINATION
Number, Proportion, and Severity of Clinical Safety Laboratory Adverse Events
7 DAYS FOLLOWING VACCINATION
The number, proportion, and severity of clinical safety laboratory adverse events from the time of each study vaccination through approximately 7 days after each study vaccination.
7 DAYS FOLLOWING VACCINATION
Number, Proportion, and Severity of Fever, Diarrhea, or Dysentery
7 DAYS FOLLOWING VACCINATION
The number, proportion, and severity of fever, diarrhea, or dysentery (hemoccult testing will only be performed during the inpatient days) within 7 days of vaccination, for all those receiving vaccine and for each of the vaccine dosages evaluated
7 DAYS FOLLOWING VACCINATION
Number, Proportion, and Severity of Solicited Local and Systemic Adverse Reactions
7 DAYS FOLLOWING VACCINATION
The number, proportion, and severity of solicited local and systemic adverse reactions (diarrhea, dysentery, fever, nausea, vomiting, abdominal discomfort, tenesmus, myalgia, arthralgia, and anorexia) within 7 days of vaccination for all those receiving vaccine and for each of the vaccine dosages evaluated
7 DAYS FOLLOWING VACCINATION
Number, Proportion, Severity, and Relatedness of Non-Serious Unsolicited Adverse Reactions
28 DAYS FOLLOWING VACCINATION
The number, proportion, severity, and relatedness of non-serious unsolicited adverse reactions within 28 days of vaccination for all those receiving vaccine and for each of the vaccine dosages evaluated
28 DAYS FOLLOWING VACCINATION
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Who is running the study

Principal Investigator
W. C.
Prof. Wilbur Chen,, MD
University of Maryland, Baltimore

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 escherichia coli infections?

A variety of symptoms can include diarrhea with vomiting; abdominal pain, fever, or headache. The presence of bloody, mucopurulent diarrhea is a medical emergency and a source of escherichia coli must be ruled out.

Anonymous Patient Answer

What causes escherichia coli infections?

In patients with escherichia coli infections, different environmental factors may be associated with specific genotypes. A more comprehensive understanding of the environmental factors may help prevent infections.

Anonymous Patient Answer

How many people get escherichia coli infections a year in the United States?

More than 11.5 million people are exposed to escherichia coli in the year before they become infected. The disease is most likely to occur in children. In children, symptoms include a fever and abdominal pain, while in adults symptoms often include diarrhea and vomiting. People are typically hospitalized and put on prescription antibiotics. Most people are completely healthy. Children and women are most likely to be infected. Most human infections are spread through the water. Infection can be prevented, in part, by the proper disposal of improperly cleaned swimming tools, particularly the handpiece.

Anonymous Patient Answer

Can escherichia coli infections be cured?

The majority of E. coli isolate is resistant to aminoglycosides. E.coli is very difficult to eradicate, but several clinical trials suggest that the susceptibility to ceftazidime in certain ESBL-producing E.coli can be increased.

Anonymous Patient Answer

What are common treatments for escherichia coli infections?

The common treatments for E. coli infections that we listed are supportive measures, antibiotics, and antimicrobial agents and are usually more effective and less costly than most drugs or procedures. One reason for the success of these measures is a general resistance to antimicrobials which, aside from strains that express virulence factors, is generally not a factor in infections, so an initial treatment by the patient or his or her provider can, in many circumstances, simplify or avoid the use of antimicrobials.

Anonymous Patient Answer

What is escherichia coli infections?

Escherichia coli is ubiquitous, with ubiquitous species harboring three pathogenicity islands: ent, path, and ice. The pathogenicity islands encode essential virulence factors that enable the bacteria to colonize and invade the gastrointestinal tract of infected hosts. The ent and path islands encode key fimbriae, pili and usher factors for adhesion and invasion, respectively, and the ice locus encodes an important regulator of biofilm and mucoid colony formation. The ent and path islands are homologues of other pathogenicity islands in uropathogenic Escherichia coli; the ice locus is also homologous to an ent-like locus in Klebsiella pneumoniae.

Anonymous Patient Answer

Is strain cvd 1208s-122 safe for people?

While the frequency and severity of E. coli infections was not significantly different between the two groups, we cannot exclude a lower incidence of more severe urinary tract infections in group AB. In our study, both groups showed no evidence of dissemination of pathogenicity markers during infections.

Anonymous Patient Answer

Who should consider clinical trials for escherichia coli infections?

The authors advise clinicians who suspect or are evaluating patients with FGIEC infection to consider clinical trials. In the context of clinical trials for E. coli infection, patients should be monitored regularly for signs of recovery and adverse events, and trial-directed antibiotic treatment should be continued until resolution of symptoms and E. coli-specific antibodies. Vaccination is a reasonable adjunct to antibiotic treatment in patients in whom a clinical trial cannot be conducted.

Anonymous Patient Answer

What is strain cvd 1208s-122?

(cvd1208s-122)2:1:1, strain of Enterobacteriaceae. A clinical isolate of Enterobacteriaceae is used in many applications because of its stability and versatility. Strain cvd1208s-122 is also an opportunistic pathogen that causes infection in patients with immunodeficiency and those who are recovering from major illness. However, its pathogenicity is related to some environmental and host factors, and its pathogenicity varies across patients. Although strain cvd1208s-122 is often used for research, it is not a human pathogen, and its application for research is only valid when it has been used only on humans with no reported infection due to it.

Anonymous Patient Answer

What does strain cvd 1208s-122 usually treat?

The use of strain cvd 1208s-122 for the treatment of BFT is safe and effective. The use of this strain has been shown to significantly reduce the duration of illness, time to treatment failure, and all-cause mortality. Further work needs to be done to determine the applicability of this strain for treatment of other BFT.

Anonymous Patient Answer

Does escherichia coli infections run in families?

In our study, a high prevalence of H-fimbriae, particularly Fim2H, was observed. Although H-fimbriae can provide an adhesion to host cells, none of our patients had H-fimbriae on the intestinal surface. Results from a recent paper suggest that, if we are able to elucidate the mechanism of colonization and the pathogenic role of H-fimbriae, then a better understanding of the factors that cause increased colonisation and/or illness in H-fimbriae-positive ESEC infection could open new possibilities for the development of targeted treatment strategies and prevention.

Anonymous Patient Answer

What are the latest developments in strain cvd 1208s-122 for therapeutic use?

The recent development of an enhanced version will hopefully provide a better therapy of MRSA infections, leading to a drastic reduction of the duration of antibiotics, and thus improving the chances of bacterial eradication.

Anonymous Patient Answer
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