Blood Donor CVD 9000

Study Overview
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Brief Summary
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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.

Official Title
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Blood Donor CVD 9000: Collection of Blood for In Vitro Studies From Healthy Adults Who Have Received Oral Cholera Vaccine (CVD 103-HgR)

Conditions
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Cholera Vaccination

Intervention / Treatment
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* Drug: Vaxchora


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccination with Oral Cholera Vaccine (Vaxchora)<br>Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. | Drug: Vaxchora<br>* 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.<br>* Other names: CVD 103-HgR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 3 | 
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 5 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 5 | 
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 8 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 8 | 
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 10 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 10 | 
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 15 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 15 | 
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 29 | 
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 1 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 1 | 
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 3 | 
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 5 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 5 | 
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 8 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 8 | 
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 10 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 10 | 
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 15 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 15 | 
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine. | Baseline and Day 29 |