NCT03724357

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)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-11-04
• Primary completion: 2021-10-28
• Completion: 2021-10-28
• First posted: 2018-10-30
• Last updated: 2023-02-02
• Results posted: 2023-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study