Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

Study Overview
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Brief Summary
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Rationale: Infections are an important worldwide cause of death, both in elderly and young children. Therefore, support of immunity could help to reduce the incidence of infections. To screen the potential of specific foods or food ingredients to support immunity, oral vaccination can serve as a model. In this study, oral cholera vaccination will be applied in human adult volunteers, and used as a model to study the support of the immune response by raw milk. Objective: To investigate whether raw milk is able to enhance the immune response as induced by oral cholera vaccination. Study design: The study is designed as a single-blind randomized controlled trial of 4 weeks. Study population: Healthy subjects of 18-50 years of age. Intervention: Raw milk, obtained from farms that comply to the high quality requirements for production of raw milk, and that has been screened according to the safety criteria for raw milk.

Official Title
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Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

Conditions
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Infection

Intervention / Treatment
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* Biological: Cholera vaccination
* Other: Raw milk


Participation Criteria
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Eligibility 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Regular cholera vaccination | Biological: Cholera vaccination<br>* Oral cholera vaccination on day 0 and day 14<br>* Other names: Dukoral;|
| Experimental: Milk bolus<br>Cholera vaccination - raw milk - bolus | Biological: Cholera vaccination<br>* Oral cholera vaccination on day 0 and day 14<br>* Other names: Dukoral;Other: Raw milk<br> <br> |
| Experimental: Milk controlled<br>Cholera vaccination - raw milk - controlled intake | Biological: Cholera vaccination<br>* Oral cholera vaccination on day 0 and day 14<br>* Other names: Dukoral;Other: Raw milk<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response |  | baseline and day 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response |  | baseline and day 18 | 
| Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response |  | baseline and day 28 | 
| Change in the cholera toxin-specific IgA and IgG antibody level in saliva as a marker of the vaccination response |  | baseline and day 18 | 
| 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 |  | baseline and day 18 | 
| Cholera toxin-specific T cell proliferation as marker of modulation of the vaccination response |  | baseline and day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunity, vaccination, milk