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Recruiting

NCT Number: NCT03971669

Blood Donor CVD 5000

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Susan Holian, RN

CONTACT

[email protected]

410-706-6156

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Ty21a Typhoid Oral Vaccine

Primary outcomes

  1. Percentage of Responders

    Time frame: approximately 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Susan Holian, RN

CONTACT

[email protected]

410-706-6156

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2030
Study completion
2030
First posted
Jun 3, 2019
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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