Blood Donor CVD 9000
Condition: Cholera Vaccination
MeSH terms: Cholera
Intervention: Vaxchora
Intervention description: One dose. Approximately 100 mL of cold or room temperature purified bottled water is placed into a clean disposable cup. The contents of the buffer sachet are added to the water and stirred. Then the contents of the active (lyophilized vaccine) sachet are added to the water and stirred for approximately 30 seconds. The reconstituted mixture should be completely ingested within 15 minutes.
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Intervention model description: Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Cholera Vaccine (Vaxchora).
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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