Older adults 73-79 years of age, birth cohorts year 1941-1947, still participating in round 6 of the Doetinchem Cohort Study.
Conditions
Interventions
Trade Name: Pneumovax 23
Product Name: Pneumovax 23
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Pharmaceutical Form: Suspension for injection in pre-filled injector
Pharmaceu
Sponsors
National Institute of Health and the Environment
Eligibility
Sex/Gender
All
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). SARS-CoV-2 booster (optional, in case of booster vaccination) Signed an additional informed consent for blood sampling after SARS-CoV-2 booster vaccination Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
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 |
|---|---|
| Main Objective: Assess the relation of frailty in 73-79 years old male and female persons with antibody responses to both vaccine pneumococcal polysaccharide serotypes and the Influenza virus vaccine strains by measuring HI titers pre and 4-6 weeks post vaccination.;Secondary Objective: Antibody responses to pneumococci, Influenza and SARS-CoV-2 till 1 year post vaccination in the relation to frailty in 73-79 years old male and female persons. Baseline numbers of immune cell subsets as well as the inflammatory status at baseline and integration of these data for their association with frailty and vaccine responsiveness. Inter-individual differences in biological ageing of the immune system with specific frailty characteristics or morbidities that are related to low vaccine responses. Mucosal salivary pneumococcal, Influenza and SARS-CoV-2-specific antibody titers related to frailty. Monocyte and lymphocyte function in subgroups of frail versus non-frail participants at baseline and compared to vaccine responsiveness. Possible interference of infection with SARS-CoV-2 on vaccine responsiveness by measuring virus-specific serum IgG antibodies to SARS-CoV-2 core protein.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 4 to 6 weeks post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Persistence of Pneumococcal antibodies will be assessed till 2 years post-vaccination and that of SARS-CoV-2 till about 18 months post 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.;Timepoint(s) of evaluation of this end point: Persistence of Pneumococcal antibodies will be assessed till 2 years post-vaccination and that of SARS-CoV-2 till about 18 months post vaccination. | — |
Countries
Netherlands
Contacts
Public ContactVIVO studieteam
National Institute of Health and the Environment (RIVM)
Outcome results
None listed