| NCT ID | NCT03971669 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Risk Reduction |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2004-01-16 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2004-01-16 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Age 18 years and older * Good general health as determined by a screening evaluation within 28 days before blood donation * Informed, written consent Exclusion Criteria: * 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 \<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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03971669 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Risk Reduction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03971669 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03971669 currently recruiting?
Yes, NCT03971669 is actively recruiting participants. Contact the research team at susan.holian@som.umaryland.edu for enrollment information.
Where is the NCT03971669 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03971669 clinical trial?
NCT03971669 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 150 participants.