Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02238548 |
Date of registration:
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09/09/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effect of Raw Milk on the Immune Response Upon Cholera Vaccination
MOSAIC |
Scientific title:
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Effect of Raw Milk on the Immune Response Upon Cholera Vaccination |
Date of first enrolment:
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July 2014 |
Target sample size:
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42 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02238548 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Els van Hoffen, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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NIZO Food Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18-50 yr
- Signed informed consent
- Availability of internet connection
- Male or female
- Willing to stop blood donation at the blood bank during the study period
Exclusion Criteria:
- Currently participating in another clinical trial
- Previous Cholera, Salmonella, or E. coli vaccination
- Tonsillectomy
- Acute gastroenteritis in the past 2 months
- Use of antibiotics in the past 2 months
- Hypersensitivity to the vaccine, to formaldehyde or to any of the excipients (sodium
salts)
- Pregnancy or lactating (pregnancy test will be performed on the vaccination days)
- Not willing to drink raw milk
- Allergic to milk or lactose-intolerant
- Disease of GI tract, liver, gall bladder, kidneys, thyroid gland
- Immune-compromised
- Use of immunosuppressive drugs
- Drug abuse, and not willing/able to stop this during the study
- Excessive alcohol usage (men: >4 consumptions/day or >20 consumptions/week; women: >3
consumptions/day or >15 consumptions/week)
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Infection
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Intervention(s)
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Biological: Cholera vaccination
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Other: Raw milk
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Primary Outcome(s)
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Change in cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response
[Time Frame: baseline and day 18]
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Secondary Outcome(s)
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Change in the cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response
[Time Frame: baseline and day 18]
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Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response
[Time Frame: baseline and day 28]
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Change in the expression of tissue homing markers on IgA and IgG antibody-secreting B cells in peripheral blood as markers of the route of modulation of the vaccination response
[Time Frame: baseline and day 18]
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Change in the cholera toxin-specific IgA and IgG antibody level in saliva as a marker of the vaccination response
[Time Frame: baseline and day 18]
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Cholera toxin-specific T cell proliferation as marker of modulation of the vaccination response
[Time Frame: baseline and day 28]
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Secondary ID(s)
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NL49042.081.14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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