De role of Cytomegalovirus-infection on T-cell dynamics after influenza vaccination in elderly

De role of Cytomegalovirus-infection on T-cell dynamics after influenza vaccination in elderly - DICE (Dynamics of t-cells In Cytomegalovirus-infected Elderly)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43423

Enrollment

Registered

2016-02-17

Start date

2016-06-09

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

immuunsysteem CMV ageing

Interventions

Intervention: In phase 2 of the study, the ten participants will receive the seasonal influenza vaccination of 2016/2017. Invasive procedures: One blood sample and one saliva sample will be collecte

drinking the start bolus of heavy water of circa 350 ml on day 0, followed by a daily dose of about 60 ml heavy water for 5 weeks.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy elderly between 60 and 80 years old

Exclusion criteria

Exclusion criteria: - Immune related diseases (allergies, diabetes etc) - Medicine use (heart, kidney failure etc) - (A history of) cancer - Drugs or extensive alcohol use - Allergy for influenza vaccine - Sea- or motion sickness

Design outcomes

Primary

Measure	Time frame
The average production rate and lifetime of different T-cell populations after influenza vaccination in CMV-positive and CMV-negative elderly (phase 2).	—

Secondary

Measure	Time frame
- Absolute numbers of different T-cell populations during the study period (both on base of phenotype markers as CMV-specific and influenza-specific T cells) (phase 2) - The presence/amount of CMV virus shedding in healthy individuals in saliva (phase 1) - The presence and level of CMV IgG antibodies (phase 1 and 2) - The presence/amount of CMV DNA and RNA in monocytes in CMV-positive individuals (phase 1) - Functionality of T cells against CMV (phase 1 and 2)	—

Measure

Time frame

- Absolute numbers of different T-cell populations during the study period (both on base of phenotype markers as CMV-specific and influenza-specific T cells) (phase 2) - The presence/amount of CMV virus shedding in healthy individuals in saliva (phase 1) - The presence and level of CMV IgG antibodies (phase 1 and 2) - The presence/amount of CMV DNA and RNA in monocytes in CMV-positive individuals (phase 1) - Functionality of T cells against CMV (phase 1 and 2)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)