Blood Donor CVD 5000

Conditions

• Risk Reduction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Vivotif Typhoid Oral Vaccine — DRUG
  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 Details

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.

Key Dates

Start date

Jan 16, 2004

Status verified

Mar 2026

Primary completion

Jun 30, 2030

Completion

Jun 30, 2030

Study Design

Enrollment

150 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Vaccination with Oral Typhoid Vaccine (Vivotif)
  Volunteers receive immunization with Vivotif oral typhoid vaccine. Blood, saliva, and stool specimens are collected at subsequent visits.

Primary Outcome Measure

Percentage of Responders [ Time Frame: approximately 5 years ]

Central Contacts

• Susan Holian, RN
  410-706-6156
  [email protected]

Locations (1)

Find similar trials in Baltimore, MD

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