Cholera VaccinationPhase 4NCT03724357
Blood Donor CVD 9000
A Phase 4 study testing Vaxchora in people with Cholera Vaccination, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera Vaccination
- What is being tested?
- Vaxchora
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2018to 28 Oct 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
About this study
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)
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
- Being tested
- Vaxchora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaxchoraDrug
Also called CVD 103-HgR
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination with Oral Cholera Vaccine (Vaxchora) | Experimental | Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Receives: Drug: Vaxchora |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start4 Nov 2018
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cholera VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Sztein, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724357
- Sponsor's protocol ID
- HP-00082377
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2018
- Last updated
- 2 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03724357
- Acronym / sponsor ID
- HP-00082377
- Conditions
- Cholera Vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 4 Nov 2018 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Posted 2 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Cholera Vaccine (Vaxchora).
| Arm | Type | Receives |
|---|---|---|
| Vaccination with Oral Cholera Vaccine (Vaxchora) | Experimental | Drug: VaxchoraVolunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaxchoraAlso: CVD 103-HgROne 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. | Drug | Vaccination with Oral Cholera Vaccine (Vaxchora) |
Primary outcome
Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
Time frame: Baseline and Day 3
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
Time frame: Baseline and Day 5
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
Time frame: Baseline and Day 8
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
Time frame: Baseline and Day 10
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
Time frame: Baseline and Day 15
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
Time frame: Baseline and Day 29
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
Time frame: Baseline and Day 1
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
Time frame: Baseline and Day 3
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
Time frame: Baseline and Day 5
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
Time frame: Baseline and Day 8
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
Time frame: Baseline and Day 10
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
Time frame: Baseline and Day 15
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
Time frame: Baseline and Day 29
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaxchora in people with Cholera Vaccination, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells (time frame: Baseline and Day 3). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.