Back to resultsBlood Donor CVD 9000
Primary Purpose
Cholera Vaccination
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vaxchora
Sponsored by
About this trial
This is an interventional basic science trial for Cholera Vaccination
Eligibility Criteria
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
Sites / Locations
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaccination with Oral Cholera Vaccine (Vaxchora)
Arm Description
Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits.
Outcomes
Primary Outcome Measures
Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 5 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 8 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 10 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 15 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 1 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 5 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 8 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 10 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 15 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine.
Secondary Outcome Measures
Full Information
NCT ID
NCT03724357
First Posted
October 26, 2018
Last Updated
January 23, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03724357
Brief Title
Blood Donor CVD 9000
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of funding
Study Start Date
November 4, 2018 (Actual)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera Vaccination
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Cholera Vaccine (Vaxchora).
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccination with Oral Cholera Vaccine (Vaxchora)
Arm Type
Experimental
Arm Description
Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits.
Intervention Type
Drug
Intervention Name(s)
Vaxchora
Other Intervention Name(s)
CVD 103-HgR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Description
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 3
Title
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Description
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 5 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 5
Title
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Description
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 8 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 8
Title
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Description
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 10 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 10
Title
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Description
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 15 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 15
Title
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Description
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 29
Title
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Description
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 1 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 1
Title
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Description
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 3
Title
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Description
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 5 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 5
Title
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Description
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 8 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 8
Title
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Description
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 10 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 10
Title
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Description
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 15 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 15
Title
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
Description
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine.
Time Frame
Baseline and Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Blood Donor CVD 9000
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