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)

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

• Status: Terminated
• Conditions: Cholera Vaccination
• Intervention / Treatment: Drug: Vaxchora

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

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

Number of Arms

1

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.

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

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

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vibrio Infections; Cholera
• Other Study ID Numbers: HP-00082377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes