Blood Donor CVD 9000

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

Sponsors

Lead Sponsor: University of Maryland, Baltimore

Source University of Maryland, Baltimore
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.

Overall Status Recruiting
Start Date 2018-11-04
Completion Date 2038-10-01
Primary Completion Date 2026-10-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Responders approximately 10 years
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Vaxchora

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.

Arm Group Label: Vaccination with Oral Cholera Vaccine (Vaxchora)

Other Name: CVD 103-HgR

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

64 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Robin Barnes, CRNP

Phone: 410-706-6156

Email: [email protected]

Location
Facility: Status: Contact: University of Maryland, Baltimore, Center for Vaccine Development and Global Health Robin Barnes, CRNP
Location Countries

United States

Verification Date

2020-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Maryland, Baltimore

Investigator Full Name: Monica McArthur, MD PhD

Investigator Title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Vaccination with Oral Cholera Vaccine (Vaxchora)

Type: Experimental

Description: Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits.

Patient Data No
Study Design Info

Allocation: N/A

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).

Primary Purpose: Basic Science

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News