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lack of funding
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccination with Oral Cholera Vaccine (Vaxchora) | Experimental | Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaxchora | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 3 |
| 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. | Baseline and Day 5 |
| 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. | Baseline and Day 8 |
| 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. | Baseline and Day 10 |
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells |
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Inclusion Criteria:
Exclusion Criteria:
1. History of any of the following medical conditions:
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:
5. Any of the following laboratory abnormalities during screening:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore, Center for Vaccine Development and Global Health | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaccination With Oral Cholera Vaccine (Vaxchora) | Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaccination With Oral Cholera Vaccine (Vaxchora) | Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 3 |
|
approximately three years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaccination With Oral Cholera Vaccine (Vaxchora) | Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcelo Sztein, MD | University of Maryland, Baltimore | 410-706-5328 | msztein@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2018 | May 3, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| C000613802 | Vaxchora |
| C414990 | cholera vaccine CVD 103-HgR |
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Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Cholera Vaccine (Vaxchora).
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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. |
| Baseline and Day 15 |
| 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. | Baseline and Day 29 |
| 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. | Baseline and Day 1 |
| 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. | Baseline and Day 3 |
| 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. | Baseline and Day 5 |
| 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. | Baseline and Day 8 |
| 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. | Baseline and Day 10 |
| 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. | Baseline and Day 15 |
| 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. | Baseline and Day 29 |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 5 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 8 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 10 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 15 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 29 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 1 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 3 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 5 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 8 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 10 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 15 |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of CD25 positive cells | Baseline and Day 29 |
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