Recruiting

Blood Donor

Sponsor:

University of Maryland, Baltimore

Code:

NCT03971669

Conditions

Risk Reduction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Vivotif Typhoid Oral Vaccine

Study Details

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

Study ID

NCT03971669

Start date

Jan 16, 2004

Status verified date

Mar, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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).

Primary outcome measure

  • Percentage of Responders [ Time Frame: approximately 5 years ]

Central Contacts and Locations

Central contacts

Susan Holian, RN

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

Locations

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

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Susan Holian, RN

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

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Typhoid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-03-27.