TCR repertoire of Immune response with age How the range of infection-fighting T cells in the body changes as people get older
Conditions
Interventions
There is no productunder investigation.In this study, we use Twinrix Adult as a tool to induce an immune response to a new antigen in Phase II participants. We are not addressing the “diagnostic, prop
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For the Hepatitis A positive cohort (only in Phase I) To be eligible for inclusion in the Hepatitis A seropositive cohort of this study, a subject must meet all of the following criteria: Participants • have recently (< 12 months) been vaccinated with Hepatitis A vaccine • are able to follow the protocol of the study during the study period For the Hepatitis A and/or Hepatitis B sero-negative cohort (of both Phase I and II)To be eligible for inclusion in the Hepatitis A seronegative cohortPhase II, a subject must meet all of the following criteria:Participants arewithout previous record of vaccination/ infection with Hepatitis A and/or Hepatitis B. able to follow the protocol of the study during the study period
Exclusion criteria
Exclusion criteria: Broadly , we want to exclude participants with a CMV infection and participants with diseases or lifestyle that have a negative impact on the immmune system. To insure this we exclude the participants with 1. Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); 2. Other current serious infections, such as malaria or a sexually transmitted disease (STD); 3. Infection with CMV 3. Active allergy; 4. Asthma, Diabetes, COPD; 5. Any previous known hepatic illness 6. Autoimmune diseases, such as rheumatoid arthriti 7. A body weight less than 50 kg; 8. Excessive alcohol consumption (more than 36 drinks per week for men, for women more than 24 drinks per week); 9. Medication use, apart from if the medication is known to affect the immune system; and painkillers, if used lessmore than twice per week (paracetamol, ibuprofen, aspirin); 10. Drug use; 11. Heart problems for which the subject is currently undergoing treatment; 12. Kidney complaints for which medication is currently used; 13. Shortness of breath or chest pain, at rest or with exertion; 14. Cancer or a history of cancer; 15. Pregnant and Nursing women 16. Blood donors who are not willing to stop donating blood in the duration of this study. 17. People with allergic reaction/sensitivity towards neomycin or yeast 18. People with Anemia. 19. People suffering from acute severe febrile illness. The reasoning for this is further elaborated in section 4.3 of C1 Onderzoeksprotocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine TCR repertoire diversity of antigen-specific T cells to Hepatitis A and/ or Hepatitis B in young and older people after vaccination with Twinrix Adult | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the gene expression profile of antigen-specific T cells to Hepatitis A and/or Hepatitis B in young and older people after vaccination with VAQTA AdultTwinrix AdultDetermine the frequency of antigen-specific T cells to Hepatitis A and Hepatitis B before and after vaccinationPhenotypic analysis of antigen-specific B and T cells to Hepatitis A and Hepatitis B before and after vaccinationCompare the B cell repertoire diversity and selection in old and young people after vaccination with Twinrix AdultVAQTA Adult. | — |
Countries
Netherlands
Contacts
Public ContactJ.A.M Borghans
Universitair Medisch Centrum Utrecht
Outcome results
None listed