Blood Donor CVD 9000
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 12/12/2018 |
| Start Date: | November 4, 2018 |
| End Date: | October 2038 |
| Contact: | Robin Barnes, CRNP |
| Email: | rbarnes@som.umaryland.edu |
| Phone: | 410-706-6156 |
Blood Donor CVD 9000: Collection of Blood for In Vitro Studies From Healthy Adults Who Have Received Oral Cholera Vaccine (CVD 103-HgR)
This is an open-label, non-randomized study. Volunteers will be vaccinated with the oral
cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration
(FDA) for travelers to developing countries. Volunteers will also be asked to provide blood
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.
cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration
(FDA) for travelers to developing countries. Volunteers will also be asked to provide blood
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.
Inclusion Criteria:
- 1. Age 18 years to 64 years at the time of enrollment
- 2. Good general health as determined by a screening evaluation within 28 days before
blood donation or vaccination
- 3. Provides written informed consent prior to initiation of any study procedures
Exclusion Criteria:
- 1. History of any of the following medical conditions:
- Diabetes
- Cancer in past 5 years (except for basal cell carcinoma of the skin and cervical
carcinoma in situ)
- Heart disease (e.g., hospitalization for a heart attack, coronary artery bypass
graft, arrhythmia, or syncope, within past 5 years. Current symptoms of heart
disease, such as dyspnea, angina, or orthopnea)
- Recurrent infections (e.g., 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
- Treatment with anti-malarial drugs within ten days prior to study vaccination
- Treatment with antibiotics within 14 days prior to study vaccination
- Immunodeficiency or immunosuppression from illness or treatment
- 2. Close contact within 7 days following study vaccination with a person who has an
immunodeficiency or immunosuppression from illness or treatment
- 3. History of cholera infection or cholera vaccination
- 4. Any of the following complete blood count (CBC) abnormalities during screening:
- white blood cells (WBC) <0.81 x lower limit of normal (LLN) or > 1.09 x upper
limit of normal (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
- 5. Any of the following laboratory abnormalities during screening:
- serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic
transaminase (SGPT) >1.5 times normal
- Positive serology for HIV antibody
- 6. Poor peripheral venous access for blood donation
- 7. Other condition that 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
- 8. Positive urine pregnancy test (HCG) on the day of vaccination
We found this trial at
1
site
Baltimore, Maryland 21201
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