Blood Donor CVD 5000

NCT03971669 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HP-00040022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk Reduction

Keywords

Typhoid

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 5 years

Study Arms (1)

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.

Drug: Vivotif Typhoid Oral Vaccine

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).

Also known as: Ty21a Typhoid Oral Vaccine

Vaccination with Oral Typhoid Vaccine (Vivotif)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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
• WBC \<3.5 or \>11 x 103/mm3;
• Hemoglobin \<12.5 or \>18 g/dl

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Risk Reduction Behavior; Typhoid Fever

Condition Hierarchy (Ancestors)

Behavior; Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Susan Holian, RN

CONTACT

410-706-6156; susan.holian@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Typhoid Vaccine (Vivotif).

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: January 16, 2004
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)