Effect of Milk on the Vaccination Response

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02924246
• Date of registration: 29/09/2016
• Prospective Registration: No
• Primary sponsor: NIZO Food Research
• Public title: Effect of Milk on the Vaccination Response MOSAIC-2
• Scientific title: MOSAIC-2: Effect of Raw Milk on the Immune Response Upon Cholera Vaccination
• Date of first enrolment: August 2016
• Target sample size: 108
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02924246
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Els van Hoffen, PhD
• Affiliation: NIZO Food Research

Key inclusion & exclusion 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

- 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

Health Condition(s) or Problem(s) studied

Infection

Intervention(s)

Biological: cholera vaccination

Other: pasteurized milk

Other: raw milk

Other: UHT milk

Primary Outcome(s)

Change in cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response [Time Frame: baseline and day 14, 28, 42]

Secondary Outcome(s)

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 14, 28, 42]

Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response [Time Frame: baseline and day 14, 28, 42]

Change in the cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response [Time Frame: baseline and day 14, 28, 42]

Secondary ID(s)

NL56906.081.16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FrieslandCampina