Blood Donor CVD 5000

Risk Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03971669
• Other study ID #: HP-00040022
• Status: Recruiting
• Phase: Phase 4
• Start date: January 16, 2004
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: University of Maryland, Baltimore
• Contact: Susan Holian, RN
• Phone: 410-706-6156
• Email: susan.holian[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Risk Reduction

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore, Center for Vaccine Development and Global Health	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Responders	Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-a)) 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-a over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-a)) by mass cytometry or flow cytometry.	approximately 5 years