The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vaccine.
- Who it may be relevant to
- Registry conditions: Aging. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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:
1. Elucidating how neutrophils kill bacteria before and after vaccination 2. Elucidate the phenotype of neutrophils before and after vaccination 3. Elucidate how neutrophils interact with B and T cell in vitro before and after vaccination 4. Measure antibody levels and function before and after vaccination 5. Correlate neutrophil responses to antibody levels and function
Interventions
- Other vaccine
Vaccination against 20 serotypes of S. pneumoniae
Primary outcome measures
- Pneumococcal Opsonophagocytic Killing Activity (OPH) by neutrophils from young versus old donors at 1 week and 1 month after vaccination [Time frame: 1 month]
Secondary outcome measures (1)
- Surface phenotype of neutrophils from young versus old donors at 1 week and 1 month after vaccination [Time frame: 1 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University at Buffalo — Buffalo
Identifiers
NCT: NCT06128915 · STUDY00007111 · R01AG068568