Vaccine Response
Conditions
Keywords
vaccine response, seroconversion, antibody
Brief summary
Assess efficacy of oral ingestion of a probiotic product on immune function in a population of healthy adult men and women in a clinical vaccination study.
Interventions
DIETARY_SUPPLEMENTProbiotic effect on influenza vaccine response
Seroconversion rate: the percentage of subjects achieving at least a 4-fold increase or an increase from \>10 to 40 in Ab titre for seronegative subjects.
Sponsors
NIZO Food Research
The Archer-Daniels-Midland Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women * Age 16 - 65 y and healthy * Self-reported regular Dutch eating habits as assessed by questionnaire (3 main meals per day) * No influenza vaccination in 2022 * Non-smokers * BMI 18.5-28 * Adherence to habitual diet * no changes during study period * Signed informed consent
Exclusion criteria
* Recent vaccination * Acute or chronic illness (e.g., diabetes mellitus) * Gastrointestinal disorders (e.g., inflammatory bowel disease) * Acute gastroenteritis in the past 2 months * Immunodeficiency disorder * Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies) * Unexplained weight loss or weight gain of \> 3 kg in the 3 months prior to pre-study screening * Alcohol or drug abuse * Mental status that is incompatible with the proper conduct of the study * History of cancer * Use of immune boosting supplements within 4 weeks before screening To be extended & specified in protocol phase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate | From baseline to week 6 | Percentage of subjects achieving at least a 4-fold increase or an increase from \>10 to 40 in Antibody titer for seronegative subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IgA antibodies against influenza | baseline, week 2, week 6 | Titer of plasma anti-influenza IgA |
| Change in IgG antibodies against influenza | baseline, week 2, week 6 | Titer of plasma anti-influenza IgG |
| Change in plasma cytokine levels | Baseline, week 2 and week 6 | Change in plasma cytokine levels (IL-10, IL-4, TFN alpha, IFN gamma) |
| Change in Gastrointestinal symptoms | baseline, week 2, week 6 | Gastrointestinal manifestations documented through Gastrointestinal Symptom Rating Scale (GSRS, 7-point graded Likert-type scale and includes 15 items combined into 5 symptom clusters - 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms) |
| Change in Incidence of respiratory infections | baseline, week 2, week 6 | Assessment of respiratory infection through questionnaire (4-point graded Likert-type scale and includes 11 items, including the 8 items comprising the Jackson common cold questionnaire - 0 = absent, 1 = mild, 2 = moderate, 3 = severe) |
| Change in IgM antibodies against influenza | baseline, week 2, week 6 | Titer of plasma anti-influenza IgM |
Countries
Netherlands
Outcome results
None listed