Blood Donor CVD 9000

March 4, 2022 updated by: Marcelo Sztein, University of Maryland, Baltimore

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

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.

Study Overview




Intervention / Treatment

Study Type


Enrollment (Actual)



  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers


Genders Eligible for Study



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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccination with Oral Cholera Vaccine (Vaxchora)
Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits.
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.
Other Names:
  • CVD 103-HgR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Responders
Time Frame: approximately 10 years
Percentage of responders by four-fold increase in vibriocidal antibody titers between pre- and post-immunization time-points.
approximately 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2018

Primary Completion (Actual)

February 12, 2020

Study Completion (Actual)

October 28, 2021

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?


Drug and device information, study documents

Studies a U.S. FDA-regulated drug product


Studies a U.S. FDA-regulated device product


product manufactured in and exported from the U.S.


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

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