BridgeMD
New treatment option for Risk Reduction
Official title Blood Donor CVD 5000
ClinicalTrials.gov ID: NCT03971669
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 risk reduction.
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. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif.
- 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
- Age 18 years and older
- Good general health as determined by a screening evaluation within 28 days before blood donation
- Informed, written consent
You likely can't join if
- History of any of the following medical illnesses:
- Diabetes
- Cancer in past 5 years (except for basal cell carcinoma of the skin and cervical carcinoma in situ)
- Heart disease (Hospitalization for a heart attack, coronary artery bypass graft, arrhythmia, or syncope, within past 5 years. Current symptoms of...
- Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
- Current drug or alcohol abuse
See the full eligibility criteria
- Age 18 years and older
- Good general health as determined by a screening evaluation within 28 days before blood donation
- Informed, written consent
- History of any of the following medical illnesses:
- Diabetes
- Cancer in past 5 years (except for basal cell carcinoma of the skin and cervical carcinoma in situ)
- Heart disease (Hospitalization for a heart attack, coronary artery bypass graft, arrhythmia, or syncope, within past 5 years. Current symptoms of heart disease - dyspnea, angina, orthopnea)
- Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
- Current drug or alcohol abuse
- Active ulcer disease or ongoing intestinal condition
- Treatment for anemia in last 6 months
- Currently being treated with anti-malarial drugs
- Any of the following laboratory abnormalities detected during medical screening:
- WBC \ 1.09 x ULN
- Hemoglobin \ 1.18 x ULN (women) or \ 1.18 x ULN (men)
- Platelet count \ 1.2 x ULN
- (For leukopheresis or blood unit donations, the following lab values are exclusionary:
- WBC \ 11 x 103/mm3;
- Hemoglobin \ 18 g/dl
- Platelet count \ 500 x 103/mm3)
- SGOT or SGPT \>1.5 times normal
- Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen
- Positive serology for hepatitis B core antibody
- Poor peripheral venous access for blood donation
- Positive RPR
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or interfere with the scientific integrity of study.
- Positive urine pregnancy test (HCG) on day of vaccination. Prior to each blood donation -females with menstrual history consistent with pregnancy. Pregnant women will not be enrolled, because immunological changes that...
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.