Blood Donor CVD 9000

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03724357
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Actual Duration (Months): 35.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholera Vaccination	Drug: Vaxchora	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• 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).Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Cholera Vaccine (Vaxchora).
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Blood Donor CVD 9000: Collection of Blood for In Vitro Studies From Healthy Adults Who Have Received Oral Cholera Vaccine (CVD 103-HgR)
• Actual Study Start Date: Nov 4, 2018
• Actual Primary Completion Date: Feb 12, 2020
• Actual Study Completion Date: Oct 28, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Responders [approximately 10 years]

   Percentage of responders by four-fold increase in vibriocidal antibody titers between pre- and post-immunization time-points.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 1. Age 18 years to 64 years at the time of enrollment
• 1. Good general health as determined by a screening evaluation within 28 days before blood donation or vaccination
• 1. 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

• 1. Close contact within 7 days following study vaccination with a person who has an immunodeficiency or immunosuppression from illness or treatment
• 1. History of cholera infection or cholera vaccination
• 1. 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

• 1. 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

• 1. Poor peripheral venous access for blood donation
• 1. 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
• 1. Positive urine pregnancy test (HCG) on the day of vaccination

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland, Baltimore, Center for Vaccine Development and Global Health	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marcelo Sztein, Assistant Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT03724357
• Other Study ID Numbers: HP-00082377
• First Posted: Oct 30, 2018
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Cholera

Study Results

No Results Posted as of Mar 21, 2022