Clinical trial NCT03724357: Blood Donor CVD 9000
Official title: Blood Donor CVD 9000: Collection of Blood for In Vitro Studies From Healthy Adults Who Have Received Oral Cholera Vaccine (CVD 103-HgR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cholera Vaccination
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Cholera Vaccine (Vaxchora).
Primary purpose: BASIC_SCIENCE

Brief 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

Primary outcomes:
measure: Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
timeFrame: Baseline and Day 3
measure: Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
timeFrame: Baseline and Day 5
measure: Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
timeFrame: Baseline and Day 8
measure: Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
timeFrame: Baseline and Day 10
measure: Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
timeFrame: Baseline and Day 15
measure: Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
timeFrame: Baseline and Day 29
measure: Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
timeFrame: Baseline and Day 1
measure: Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
timeFrame: Baseline and Day 3
measure: Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
timeFrame: Baseline and Day 5
measure: Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
timeFrame: Baseline and Day 8
measure: Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
timeFrame: Baseline and Day 10
measure: Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
timeFrame: Baseline and Day 15
measure: Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
timeFrame: Baseline and Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore, Center for Vaccine Development and Global Health
state: Maryland
Study officials:
References: