Healthy volunteers above 25 years of age
Conditions
Interventions
Trade Name: Prevenar-13
Product Code: EU/1/09/590
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Pharmaceuti
Sponsors
National Institute of Health and the Environment
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Be 25 years or older at the time of inclusion. •Have received a seasonal influenza vaccination in previous season (2018-2019). •Be capacitated. •Have signed Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 165
Exclusion criteria
Exclusion criteria: •Having had a previous pneumococcal vaccination (PCV or the 23-valent pneumococcal polysaccharide vaccine (PPV23)). •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 (local incl. 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 recent past. •Receipt of an organ- or bone marrow transplant •Have a (functional) asplenie. •Receipt of chemotherapy in the last 3 years. •Receipt of blood products or immunoglobulin, within three months of 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 anemia, measured as Hb < ( 8,5 mmol/l for men and 7,5 mmol/l for woman; NHG standard Anemia) •Known to be positive for human immunodeficiency virus (HIV), and/or hepatitis C virus (HCV) and/or hepatitis B virus (HBV). Exclusion criteria COVID-19 vaccination study • Treatment with COVID-19 monoclonal antibodies less that 3 months before COVID-19 vaccination. • Known pregnancy at the moment of COVID-19 vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Compare serotype-specific IgG antibody response to pneumococcal PCV13 vaccination in older adults with the response in middle-aged adults and adults one month after vaccination. •Compare influenza vaccine strain-specific serum antibody titers in older adults with the response in middle-aged adults and adults one month after influenza vaccination. ;Secondary Objective: Comparison of age groups: QIV, PCV13 (total and protein-specific) and SARS-CoV-2 vaccine induced Ab responses protein-specific T-cell responses pre- and post-vaccination. Determine the impact of clinical baseline status and changes in baseline status, as a predictive marker for vaccine response. Determine the impact of (immunological) biomarkers status at baseline as a predictive marker for vaccine response for each subject. Kinetics and longevity of SARS-CoV-2 specific Ab subclasses and functionality induced by COVID-19 (booster) vaccination. Assessment of the magnitude, characteristics and longevity of the adaptive cellular response induced by the SARS-CoV-2 vaccine: activation, phenotype and function of vaccine-specific (effector, memory, regulatory) T-cells and B-cells. ;Primary end point(s): 1.Pneumococcal serotype- specific serum IgG antibody concentrations (GMCs) pre-vaccination (T5) and one-month post (T8) PCV13 vaccination measured by bead-based multiplex immune assay. 2.Influenza vaccine strain-specific serum antibody titers (GMTs) will be measured pre- vaccination (T0) and one-month post-influenza vaccination (T4) by Hemagglutinin Inhibition (HI) assay. ;Timepoint(s) of evaluation of this end point: 1. 6 months and 7 months after start study 2. 1 month and 2 months after start of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Influenza strain-specific and pneumococcal serotype-specific antibody titers in serum pre- and post-vaccination: ((T1, T5, T3, T7, T4, T8, T5, T9, T10). 2.CRM197-specific serum antibody titers before (T5) and at 7 days (T7), 1 (T8) and 6 (T9) months post pneumococcal vaccination 3. Influenza-specific and CRM197-specific T-cells measured by Enzyme-Linked Immunosorbent Spot (ELISPOT) in peripheral blood mononuclear cells (PBMCs) of pre- (T0; T5) and post-vaccination samples (T3, T4, T7, T8). 4. A- health status assessment will be done by questionnaires, which include demographics, the short-form (SF) 36 health assessment of quality of life that covers 8 different sections (vitality, physical functioning, pain, general health perception, physical role functioning, emotional role functioning, social role functioning and mental health), a EQ-5D QoL-assessment, socio-economic status (SES), chronic diseases and medication use (including other vaccines), level of exercise, body mass index (BMI) and life style characteristics. In addition, grip strength and blood pressure will be measured by standardized protocols. Questionnaires and measurements will be done at 3 time points during the study at T0, T5 and T9. A deficit accumulation index will be calculated for each subject and the subjects will be ranked based on this index. 5. Measure absolute numbers of immune cell types, a.o. lymphocytes, granulocytes and monocytes, in whole blood by Trucount (T0, T5). Measure cell frequency, phenotype and functional capacity of immune cells by Fluorescence-Activated Cell Sorting (FACS). Measure priming efficacy of T-cells specific for influenza or model antigens. Measure systemic and local immune and inflammatory profiles by systems immunology, serology and molecular methods in serum, saliva and swabs. (T0, T5, T9). Determine biomarkers, such as creatinine and cystatin C in plasma. Determine both broad and targeted transcriptome profile at baseline (T0, T | — |
Countries
Netherlands
Contacts
Public ContactVITAL studyteam
National Institute of Health and the Environment (RIVM)
Outcome results
None listed