vaccination efficacy in healthy seniors vaccination efficacy vaccine-specific antibody response
Conditions
Interventions
The subjects in this study will be treated with an ITF formulation or a placebo
(glucose) derived from products in the food industry and which do not have any
negative side effects. 8g of fibres per
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Females and males age >55 years Healthy subjects Caucasian subjects Written informed consent Dutch speaking subjects, i.e. subjects understanding spoken and written Dutch language
Exclusion criteria
Exclusion criteria: - Presence of acute or chronic diseases (e.g. diabetes mellitus) - Gastrointestinal disorders (e.g. inflammatory bowel disease, celiac disease) - Gastrointestinal surgery - Treatment with antibiotics within 6 months of the start of the study - Prior vaccination with hepatitis B - Previous hepatitis B infection - Immunodeficiency*s - Use of anti-coagulant drugs - Vegetarians - Food intolerance (e.g. gluten or lactose)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameter is the hepatitis B specific antibody titer after the second shot of hepatitis B vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters are peripheral immune cell populations and faecal parameters (microbiota profile, short chain fatty acid levels and IgA levels), to determine the underlying mechanism of the ITF stimulated increase in titer response. | — |
Countries
Netherlands
Outcome results
None listed