Risk ReductionPhase 4NCT03971669
Blood Donor CVD 5000
A Phase 4 study testing Vivotif Typhoid Oral Vaccine in people with Risk Reduction, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction
- What is being tested?
- Vivotif Typhoid Oral Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2004to 30 Jun 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Good general health as determined by a screening evaluation within 28 days before blood donation
- Informed, written consent
Who cannot join
- 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
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- 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 <0.81 x LLN or > 1.09 x ULN
- Hemoglobin <0.91 x LLN or >1.18 x ULN (women) or <0.92 x LLN or >1.18 x ULN (men)
- Platelet count <0.8 x LLN or > 1.2 x ULN
- (For leukopheresis or blood unit donations, the following lab values are exclusionary:
- WBC <3.5 or >11 x 103/mm3;
- Hemoglobin <12.5 or >18 g/dl
- Platelet count <150 or >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 occur during pregnancy may interfere with laboratory assays.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
Susan Holian, RN, 410-706-6156, susan.holian@som.umaryland.edu
About this study
Official title: Collection of Blood Samples for In-Vitro Studies From Healthy Adult Blood Donors Who Have Received Oral Typhoid Vaccine (TY21A)
This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood, saliva, and stool specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.
- Conditions
- Risk Reduction
- Being tested
- Vivotif Typhoid Oral Vaccine
- Keywords
- Typhoid
- Medical subject headings
- Risk Reduction Behavior, Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivotif Typhoid Oral VaccineDrug
Also called Ty21a Typhoid Oral Vaccine
The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
| Study group | Role | What they receive |
|---|---|---|
| Vaccination with Oral Typhoid Vaccine (Vivotif) | Experimental | Volunteers receive immunization with Vivotif oral typhoid vaccine. Blood, saliva, and stool specimens are collected at subsequent visits. Receives: Drug: Vivotif Typhoid Oral Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders
Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry. Responders will be defined as those volunteers showing increases post-immunization of >0.1% of positive CD8+ cells for IFN-gamma or TNF-α over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry.
Measured: approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start16 Jan 2004
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Typhoid Vaccine (Vivotif).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilbur Chen, MD, MS, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971669
- Sponsor's protocol ID
- HP-00040022
- Status last verified
- Mar 2026
- First submitted
- 29 May 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No