Blood Donor CVD 9000

NCT ID: NCT03724357

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-04
• Study Completion Date: 2021-10-28

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.

Conditions

Cholera Vaccination

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Vaccination with Oral Cholera Vaccine (Vaxchora)

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

Group Type: EXPERIMENTAL

Vaxchora

Intervention Type: DRUG

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.

Interventions

Vaxchora

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.

Intervention Type: DRUG

Other Intervention Names

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Sztein

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00082377

Identifier Type: -

Identifier Source: org_study_id