Vaccination response, immune support in healthy elderly Other
Conditions
Interventions
Subjects will be randomly allocated to receive the active product Lacprodan® OPN-10 or a placebo product with maltodextrin. Both products are administered orally twice per day for 14 weeks. The dose o
Sponsors
Arla Foods (Denmark)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =60 years and healthy 2. Self-reported regular Dutch eating habits as assessed by questionnaire (3 main meals per day) 3. Anti hepatitis B antibody titer = 4 IU/L 4. Non-smokers (ex-smokers can participate) 5. BMI =22 and =30 6. In good health as assessed during screening, and the medical investigator’s professional judgment 7. Adherence to habitual diet, no changes during study period 8. Signed informed consent 9. Ability to follow Dutch verbal and written instructions 10. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned 11. Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years 12. Willing to comply with study procedures, including intake of study products and collection of stool and blood samples 13. Willingness to give up blood donation starting at screening and during the entire study
Exclusion criteria
Exclusion criteria: 1. Prior HB vaccination or infection 2. Any vaccination in the past month or any scheduled vaccination during the study period 3. Acute infection in the past month 4. Treatment with oral antibiotics within 2 months of the start of the study, 5. Serious progressive disease or non-stabilized chronic illness (e.g., diabetes mellitus, cardiac insufficiency, respiratory insufficiency, cancer, chronic kidney or liver disease) 6. History of cancer 7. Gastrointestinal disorders (e.g., inflammatory bowel disease) 8. Immunodeficiency or autoimmune disorder 9. Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies) 10. Allergy or hypersensitivity to milk proteins, or lactose intolerance 11. Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to pre-study screening 12. Evidence of current excessive alcohol consumption (>4 consumptions/day or >20 consumptions/week) or drug (ab)use 13. Mental status that is incompatible with the proper conduct of the study 14. Not having a general practitioner, not allowing disclosure of participation to the general practitioner or not allow to inform the general practitioner about abnormal results. 15. Participation in any clinical trial including blood sampling and/or administration of substances starting 1 month prior to study start and during the entire study. 16. Personnel of NIZO, EBMR or AFI, their partner and their first- and second-degree relatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of responders to hepatitis B vaccination. A “responder” is defined as a subject attaining anti-hepatitis B antibody titres >10 IU/L at Visit 7 (2 weeks after the third vaccination). The Hepatitis B titer is analysed with an ELISA assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in serum anti-hepatitis B antibody titres from baseline (V1) to 14 days after the second vaccination (V6) and 14 days after the third vaccination (V7) determined with ELISA. 2. Change in circulating cytokines from baseline to 8 weeks intervention (V4) and to the end of the study (V7). The analyses will be performed with a multiplex assay. 3. Change in serum levels of P1NP and CTX-1 (as markers of bone formation and bone resorption) from baseline to 8 weeks intervention. Analyses will be performed by radioimmunoassay and electrochemical luminescence immunoassay respectively. 4. Change in plasma levels of hOPN and bOPN from baseline to 4 weeks and 8 weeks intervention. hOPN and bOPN will be analysed with an ELISA assay. 5. Change in serum LPS binding protein (LBP) from baseline to 8 weeks intervention. Serum LBP will be analysed with an ELISA assay. 6. Incidence of self-reported upper respiratory tract infections or lower respiratory tract infections during the trial, assessed by weekly questionnaires 7. Safety monitoring by routine assays for hematology and serum clinical chemistry throughout the study | — |
Countries
Netherlands
Contacts
Public ContactSimon Bøge Riis
Outcome results
None listed