respons van immuunsysteem op vaccinatie-challenge (upper) airway infection (upper) respiratory tract infection
Conditions
Interventions
1) 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 (a.o. presence of s
2) commercially
available full-fat UHT milk
3) commercially available full-fat pasteurized
milk
Sponsors
FrieslandCampina Nederland BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 18-50yr Male or female Signed informed consent Willing to stop blood donation during the study period
Exclusion criteria
Exclusion criteria: Currently participating in another clinical trial Previous cholera or E. coli vaccination Tonsillectomy Acute gastroenteritis in the past 2 months use of antibodies 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 made available in case of doubt on vaccination days) Not willing to drink raw milk Not willing to adhere to diet restrictions during the study Allergy to milk or lactose intolerant Disease of GI tract, liver, gall bladder, kidneys, thyroid gland Immune-compromised Use of immune-suppressive drugs Drug abuse, and not willing 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the increase in vaccine-specific secretory IgA levels detectable in serum at day 14 after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are vaccine-specific secretory IgA (and IgG) levels in saliva, nasal wash and feces. | — |
Countries
Netherlands
Outcome results
None listed