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New treatment option for Typhoid and/or Cholera Vaccination
Official title CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
ClinicalTrials.gov ID: NCT03705585
What this study is testing
What is Vivotif Typhoid Oral Vaccine?
Vivotif Typhoid Oral Vaccine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for typhoid and/or cholera vaccination.
Also referred to as Ty21a Typhoid Oral Vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 1\. Age 18 years and older
- 2\. Already scheduled to undergo an EGD or colonoscopy for screening, surveillance, or a medically-indicated work-up at the University of Maryland...
- 3\. Able to provide written informed consent prior to initiation of any study procedures
- 4\. Healthy, as defined by considered fit to undergo outpatient elective EGD/colonoscopy by the evaluating health care provider
You likely can't join if
- 1\. Pregnancy or nursing mother
- 2\. Known coagulopathy or bleeding disorder preventing mucosal biopsy
- 3\. History of Crohn's disease or ulcerative colitis
- 4\. For people undergoing lower endoscopy (colonoscopy) only: Surgical removal of the ileocecal valve or any part of the small or large intestine...
- 5\. Allergic reaction to oral typhoid or cholera vaccine in the past
- 6\. Immunosuppression from illness or treatment, including
See the full eligibility criteria
- 1\. Age 18 years and older
- 2\. Already scheduled to undergo an EGD or colonoscopy for screening, surveillance, or a medically-indicated work-up at the University of Maryland Medical Center (main campus or Midtown)
- 3\. Able to provide written informed consent prior to initiation of any study procedures
- 4\. Healthy, as defined by considered fit to undergo outpatient elective EGD/colonoscopy by the evaluating health care provider
- 1\. Pregnancy or nursing mother
- 2\. Known coagulopathy or bleeding disorder preventing mucosal biopsy
- 3\. History of Crohn's disease or ulcerative colitis
- 4\. For people undergoing lower endoscopy (colonoscopy) only: Surgical removal of the ileocecal valve or any part of the small or large intestine (non-complicated appendectomy will be considered eligible)
- 5\. Allergic reaction to oral typhoid or cholera vaccine in the past
- 6\. Immunosuppression from illness or treatment, including
- immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
- leukemia, lymphoma, or cancers (localized non-melanoma skin cancers which are deemed inactive should be considered eligible)
- 7\. Receipt of any other vaccine two weeks prior to receipt of Ty21a or CVD 103-HgR
- 8\. Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.