The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses
- Conditions
- Aging
- Interventions
- Other: vaccine
- Registration Number
- NCT06128915
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vaccination with Prevnar. vaccine Intramuscular vaccination with Prevnar 20
- Primary Outcome Measures
Name Time Method Pneumococcal Opsonophagocytic Killing Activity (OPH) by neutrophils from young versus old donors at 1 week and 1 month after vaccination 1 month OPH will be determined by measuring the percentage of S. pneumoniae bacteria killed in vitro by neutrophils from donors
- Secondary Outcome Measures
Name Time Method Surface phenotype of neutrophils from young versus old donors at 1 week and 1 month after vaccination 1 month Phenotype will be determined by measuring the expression of surface receptors on neutrophils ex vivo by flowcytometry from donors
Trial Locations
- Locations (1)
University at Buffalo
🇺🇸Buffalo, New York, United States