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

University at Buffalo (UB)

Status and phase: Enrolling; Phase 4

Conditions: Aging

Treatments: Other: vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06128915

R01AG068568 (U.S. NIH Grant/Contract)

STUDY00007111

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Vaccination with Prevnar.

Experimental group

Description:

Intramuscular vaccination with Prevnar 20

Treatment:

Other: vaccine