Blood Donor CVD 5000
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03971669|
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : May 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Risk Reduction||Drug: Vivotif Typhoid Oral Vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Typhoid Vaccine (Vivotif).|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Collection of Blood Samples for In-Vitro Studies From Healthy Adult Blood Donors Who Have Received Oral Typhoid Vaccine (TY21A)|
|Actual Study Start Date :||January 16, 2004|
|Estimated Primary Completion Date :||June 30, 2024|
|Estimated Study Completion Date :||June 30, 2024|
Experimental: Vaccination with Oral Typhoid Vaccine (Vivotif)
Volunteers receive immunization with Vivotif oral typhoid vaccine. Blood, saliva, and stool specimens are collected at subsequent visits.
Drug: Vivotif Typhoid Oral Vaccine
The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
Other Name: Ty21a Typhoid Oral Vaccine
- Percentage of Responders [ Time Frame: approximately 5 years ]Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry. Responders will be defined as those volunteers showing increases post-immunization of >0.1% of positive CD8+ cells for IFN-gamma or TNF-α over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971669
|Contact: Robin Barnes, CRNPemail@example.com|
|United States, Maryland|
|University of Maryland, Baltimore, Center for Vaccine Development and Global Health||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Robin Barnes, CRNP 410-706-6156 firstname.lastname@example.org|