Blood Donor CVD 5000

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · May 31, 2019

Keywords

ClinConnect Summary

The Blood Donor CVD 5000 trial is studying how a typhoid oral vaccine, called Vivotif, can help improve our understanding of how the immune system protects against certain infections. This vaccine is already approved by the FDA for travelers going to developing countries. In this study, volunteers who are 18 years or older and in good health will receive the vaccine and provide blood, saliva, and stool samples over a period of up to eight years. These samples will help researchers learn more about the body’s immune responses, which could be useful for fighting other infections in the future.

To participate, individuals must be generally healthy and meet specific criteria, such as not having serious medical conditions like diabetes or heart disease. They will need to provide written consent and undergo a health screening before joining the study. Participants can expect to receive the vaccine and then provide samples periodically. It's important to note that pregnant women and those with certain health issues will not be eligible for this trial to ensure their safety and the integrity of the research.

Gender

ALL

Eligibility criteria

• 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.