virale infectieziekten, immuunsysteem Aging Prevention
Conditions
Interventions
None listed
Sponsors
RIVM
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Participant in round 6 of the Doetinhem Cohort study and born between 1941-1947 • Willing to receive the PPV23 vaccine in 2020 • Have signed Informed Consent SARS-CoV-2 part (optional) Signed an additional informed consent for blood sampling after SARS-CoV2 vaccination (optional). Signed an additional informed consent for blood sampling after SARS-CoV-2 booster vaccination (optional, in case of booster vaccination).
Exclusion criteria
Exclusion criteria: • Having had a previous pneumococcal vaccination • Known or suspected allergy to any of the vaccine components or having experienced a previous severe adverse reaction to any vaccine. • Receipt of any high-dose (>= 20 mg of prednisone daily or equivalent) daily corticosteroids (locally applied including inhaled steroids are acceptable) within 2 weeks of study entry. • Repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) in the last month, or, as medically prescribed, within two weeks after the vaccination. • Receipt of a recent organ- or bone marrow transplant during the last 5 years . • Have an anatomical or functional asplenia. • Receipt of blood products or immunoglobulin, within one month of the study entry. • Known or suspected coagulation disorder that in the opinion of the investigator would contraindicate against receiving an intramuscular injection or undergo frequent blood sampling. • Known to be positive for human immunodeficiency virus (HIV), and/or hepatitis C virus (HCV) and/or hepatitis B virus (HBV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody levels for all PPV23 vaccine serotypes and for the 4 Influenza virus vaccine types at 4 to 6 weeks post vaccination. IgG antibody levels will be considered as the quantity that expresses the strength of the of response | — |
Secondary
| Measure | Time frame |
|---|---|
| Persistence of Pneumococcal antibodies will be assessed till 2 years post-vaccination and that of SARS-CoV-2 till about 18 months post vaccination (or in case of a SARS-CoV-2 booster dose 12 months post booster vaccination). Potential cellular and serological biomarkers before vaccination will be identified for their association with immune response to vaccination. In addition, the possible interference of infection with SARS-CoV-2 in vaccine responsiveness will be determined by measuring serum antibodies to SARS-CoV-2 virus core protein. | — |
Countries
Netherlands
Outcome results
None listed