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Vaccine

Vaxchora for Typhoid and/or Cholera Vaccination

Phase 4

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

Study Summary

This trial will study the effect of two different vaccines against typhoid fever and cholera on the immune system and bacteria in the intestine. Patients will be divided into three groups, with some receiving the vaccine before their endoscopy and some receiving it after. Tissue, blood, saliva and stool samples will be collected to study the body's response to the vaccines.

Who is the study for?

This trial is for adults over 18 who are healthy and already scheduled for an EGD or colonoscopy at the University of Maryland Medical Center. They must be able to consent and not have Crohn's, ulcerative colitis, immunosuppression, recent vaccines, pregnancy, certain cancers, or a history of severe vaccine allergy.Check my eligibility

What is being tested?

The study examines how typhoid (Vivotif) and cholera (Vaxchora) vaccines affect the immune system and gut bacteria. Participants will either receive vaccinations before or after their endoscopies or have an endoscopy without vaccination. Samples like tissue and blood will be collected.See study design

What are the potential side effects?

While specific side effects aren't listed here, Vivotif and Vaxchora can typically cause mild reactions such as soreness at injection site, low-grade fever, headache, fatigue, nausea or stomach pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Responders

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Vaccination, EndoscopyExperimental Treatment2 Interventions

Individuals receive immunization with Vivotif typhoid vaccine and/or Vaxchora cholera vaccine prior to routine endoscopic examination. During endoscopy, small bowel biopsies will be obtained to examine immune responses and microbiota at the mucosal level; brushings might also be obtained.

Group II: Endoscopy, Vaccination, EndoscopyExperimental Treatment2 Interventions

Individuals receive immunization with Vivotif typhoid vaccine and/or Vaxchora cholera vaccine after initial endoscopic exam and specimen collection and prior to a routine follow up endoscopic examination during which additional specimens will be collected.

Group III: Endoscopy Without VaccinationActive Control1 Intervention

Individuals do not receive immunization but consent to collection of specimens during endoscopy. The specimens to be collected in all three groups include stool, saliva, and small bowel biopsies (terminal ileum if colonoscopy performed, duodenum if EGD performed).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,416 Total Patients Enrolled

Media Library

Vaxchora (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03705585 — Phase 4

Typhoid and/or Cholera Vaccination Research Study Groups: Endoscopy Without Vaccination, Vaccination, Endoscopy, Endoscopy, Vaccination, Endoscopy

Typhoid and/or Cholera Vaccination Clinical Trial 2023: Vaxchora Highlights & Side Effects. Trial Name: NCT03705585 — Phase 4

Vaxchora (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03705585 — Phase 4

Frequently Asked Questions

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

Is there an opportunity to join this clinical experimentation at present?

"Affirmative. Clinicaltrials.gov hosts information that indicates this clinical trial is actively searching for participants and was initiated on November 5th 2018, with the latest update being issued on May 2nd 2022. The study plans to recruit 240 patients from a solitary medical site."

Answered by AI

What is the magnitude of participants in this research?

"Confirmed. According to the clinicaltrials.gov database, this study is still recruiting patients; it was initially posted on November 5th 2018 and updated most recently on May 2nd 2022. For now, a total of 240 participants are being sought from one location."

Answered by AI

Has the FDA given their stamp of approval for Vaxchora?

"The safety profile of Vaxchora earned a score of 3 on our team's scale due to it being approved for use in Phase 4 trials."

Answered by AI

Has any prior research been done on Vaxchora?

"Currently, the landscape for Vaxchora clinical trials consists of 5 active studies. One is in its final stage (Phase 3), and 8 different medical sites are running these investigations across Rautahat and Dharan."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera

Bruce Greenwald 2018. "CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03705585.