MOSAIC study: MOdel to Study upper Airway Immunity upon Cholera vaccination

MOSAIC study: MOdel to Study upper Airway Immunity upon Cholera vaccination - MOSAIC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41015

Enrollment

Registered

2014-07-15

Start date

2014-10-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

airway infection upper respiratory tract infection

Interventions

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 spec

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
Primary outcome is the increase in vaccine-specific secretory IgA or IgG levels detectable in nasal washes, as a measure for upper airway immunity.	—

Secondary

Measure	Time frame
Secondary outcomes are: - Vaccine-specific secretory IgA (and IgG) levels in saliva, serum and feces - Percentage of antigen-specific IgA or IgG positive B cells with airway-homing potential - Antigen-specific T cell proliferation. In case of positive outcomes on the primary and/or secondary outcome parameters, stored serum, saliva, nasal wash or fecal material may also be explored by analysis of markers of inflammation or gut permeability (such as calprotectin, CRP, cytokines/chemokines, I-FABP).	—

Measure

Time frame

Secondary outcomes are: - Vaccine-specific secretory IgA (and IgG) levels in saliva, serum and feces - Percentage of antigen-specific IgA or IgG positive B cells with airway-homing potential - Antigen-specific T cell proliferation. In case of positive outcomes on the primary and/or secondary outcome parameters, stored serum, saliva, nasal wash or fecal material may also be explored by analysis of markers of inflammation or gut permeability (such as calprotectin, CRP, cytokines/chemokines, I-FABP).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)