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NCT Number: NCT06128915

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

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.

Recruiting

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University at Buffalo

Buffalo, New York, 14203, United States

Location status: Recruiting

Location contact

Catherine Wrona

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaccine

Other

Vaccination against 20 serotypes of S. pneumoniae

Primary outcomes

  1. Pneumococcal Opsonophagocytic Killing Activity (OPH) by neutrophils from young versus old donors at 1 week and 1 month after vaccination

    Time frame: 1 month

    OPH will be determined by measuring the percentage of S. pneumoniae bacteria killed in vitro by neutrophils from donors

Secondary outcomes

  1. Surface phenotype of neutrophils from young versus old donors at 1 week and 1 month after vaccination

    Time frame: 1 month

    Phenotype will be determined by measuring the expression of surface receptors on neutrophils ex vivo by flowcytometry from donors

Study contacts

Contact information is provided by the study sponsor or research team.

Elsa Bou Ghanem, PhD

CONTACT

[email protected]

7168292422

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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