The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses

Study Overview
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Brief Summary
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This study focuses on the role of neutrophils in shaping the adaptive immune response to the anti-pneumococcal vaccine Prevnar-13 in young and elderly adults.

Detailed Description
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This study focuses on the role of neutrophils in shaping the adaptive immune response to the anti-pneumococcal vaccine Prevnar in young and elderly adults. This study involves direct vaccination of human volunteers. The endpoints will be determining how vaccination affects neutrophil responses and linking those neutrophil responses to antibody responses following vaccination. The main results will be: Elucidating how neutrophils kill bacteria before and after vaccination Elucidate the phenotype of neutrophils before and after vaccination Elucidate how neutrophils interact with B and T cell in vitro before and after vaccination Measure antibody levels and function before and after vaccination Correlate neutrophil responses to antibody levels and function

Official Title
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The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses

Conditions
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Aging

Intervention / Treatment
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* Other: vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes Have not been vaccinated with any licensed or experimental pneumococcal vaccine Ages 21-40; and ≥65. Individuals >60 years old will also be recruited in case we find no unvaccinated people ≥65 years old Free of acute infections within the last 2 weeks Did not take any anti-inflammatory medicine in the last week Did not ingest alcohol in the last 24 hours Ability and willingness to provide consent Exclusion Criteria: Previous vaccination with any licensed or experimental pneumococcal vaccine Known hypersensitivity to vaccination and vaccine components Immune deficiency Use of immune-modulating or suppressive drugs Malignancies within the last 2 years Known hematological, rheumatic and inflammatory diseases Known chronic infections Poorly controlled chronic cardiovascular and metabolic conditions Pregnancy Dementia

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Vaccination with Prevnar.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccination with Prevnar.<br>Intramuscular vaccination with Prevnar 20 | Other: vaccine<br>* Vaccination against 20 serotypes of S. pneumoniae<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal Opsonophagocytic Killing Activity (OPH) by neutrophils from young versus old donors at 1 week and 1 month after vaccination | OPH will be determined by measuring the percentage of S. pneumoniae bacteria killed in vitro by neutrophils from donors | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface phenotype of neutrophils from young versus old donors at 1 week and 1 month after vaccination | Phenotype will be determined by measuring the expression of surface receptors on neutrophils ex vivo by flowcytometry from donors | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Neutrophils, Streptococcus pneumoniae, Pneumococcal conjugate vaccine