Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 4
Study Type
Interventional
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)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Vaccination with Oral Cholera Vaccine (Vaxchora)
Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits.
  • Drug: 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.
    Other names:
    • CVD 103-HgR

Recruiting Locations

University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland 21201
Contact:
Robin Barnes, CRNP

More Details

NCT ID
NCT03724357
Status
Recruiting
Sponsor
University of Maryland

Study Contact

Robin Barnes, CRNP
410-706-6156
rbarnes@som.umaryland.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.