Vaccination with the typhoid oral vaccine Vivotif for blood donors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, non-randomized study involves volunteers receiving the typhoid oral vaccine, Vivotif, which is FDA-approved for travelers to developing countries. Participants will provide blood, saliva, and stool specimens over a follow-up period of up to eight years. The collected specimens will help researchers understand the immunological mechanisms that provide protection against typhoid and may be applicable to other enteric pathogens. The study aims to enhance knowledge about risk reduction for typhoid fever.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Maryland, Baltimore, Center for Vaccine Development and Global Health
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Susan Holian, RN
• Email: susan.holian@som.umaryland.edu
• Phone: 410-706-6156

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.