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Effect of Raw Milk on the Immune Response Upon Cholera Vaccination (MOSAIC)

Primary Purpose

Infection

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Cholera vaccination

Raw milk

About this trial

This is an interventional prevention trial for Infection focused on measuring immunity, vaccination, milk

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

NIZO food research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Milk bolus

Milk controlled

Arm Description

Regular cholera vaccination

Cholera vaccination - raw milk - bolus

Cholera vaccination - raw milk - controlled intake

Outcomes

Primary Outcome Measures

Change in cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response

Secondary Outcome Measures

Change in the cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response

Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response

Change in the cholera toxin-specific IgA and IgG antibody level in saliva as a marker of the vaccination response

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

Cholera toxin-specific T cell proliferation as marker of modulation of the vaccination response

Full Information

NCT ID

NCT02238548

First Posted

September 9, 2014

Last Updated

March 28, 2017

Sponsor

NIZO Food Research

Collaborators

FrieslandCampina

1. Study Identification

Unique Protocol Identification Number

NCT02238548

Brief Title

Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

Acronym

MOSAIC

Official Title

Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NIZO Food Research

Collaborators

FrieslandCampina

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection

Keywords

immunity, vaccination, milk

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Regular cholera vaccination

Arm Title

Milk bolus

Arm Type

Experimental

Arm Description

Cholera vaccination - raw milk - bolus

Arm Title

Milk controlled

Arm Type

Experimental

Arm Description

Cholera vaccination - raw milk - controlled intake

Intervention Type

Biological

Intervention Name(s)

Cholera vaccination

Other Intervention Name(s)

Dukoral

Intervention Description

Oral cholera vaccination on day 0 and day 14

Intervention Type

Other

Intervention Name(s)

Raw milk

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response

Time Frame

baseline and day 28

Title

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

Title

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

Title

Cholera toxin-specific T cell proliferation as marker of modulation of the vaccination response

Time Frame

baseline and day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Els van Hoffen, PhD

Organizational Affiliation

NIZO Food Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

NIZO food research

City

Ede

ZIP/Postal Code

6718 ZB

Country

Netherlands

12. IPD Sharing Statement

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Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

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