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Blood Donor CVD 9000

NCT03724357 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-02-02

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-04
Primary Completion
2021-10-28
Completion
2021-10-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03724357 on ClinicalTrials.gov