A Phase 4 interventional study of Vaxchora in Cholera Vaccination, sponsored by University of Maryland, Baltimore. Terminated at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Basic science
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.
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's enrollment of 3 is below the median of 262 across 72 interventional studies indexed under Cholera.
Browse Cholera studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History of any of the following medical conditions:
Any of the following complete blood count (CBC) abnormalities during screening:
Any of the following laboratory abnormalities during screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits.
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.
Also known as: CVD 103-HgR
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Day 10
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Day 29
| Milestone | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Started | 3 |
| Completed | 1 |
| Not completed | 2 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | -0.013 ± 0.023 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | 0.013 ± 0.061 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | 0.013 ± 0.050 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | 0.153 ± 0.045 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | 0.047 ± 0.015 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells | 0.043 ± 0.035 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | 0.01 ± 0.01 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | 1.06 ± 0.98 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | 0.32 ± 0.25 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | 0.18 ± 0.16 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | 0.10 ± 0.18 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | 0.27 ± 0.36 |
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.
| percentage of CD25 positive cells | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 | 0.00 ± 0.00 |
Collected over approximately three years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vaccination With Oral Cholera Vaccine (Vaxchora) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Age, Continuous(years) | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Mean | 28 (25 to 33) |
| Sex: Female, Male(Participants) | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| Female | 1 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Vaccination With Oral Cholera Vaccine (Vaxchora) |
|---|---|
| United States | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Vaxchora
University of Maryland, Baltimore →