NCT03971669

Blood Donor CVD 5000

Collection of Blood Samples for In-Vitro Studies From Healthy Adult Blood Donors Who Have Received Oral Typhoid Vaccine (TY21A)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Risk Reduction

Interventions

Type	Name	Description
DRUG	Vivotif 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).

Timeline

• Start date: 2004-01-16
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2019-06-03
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study