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

April 2, 2026 updated by: Elsa Bou Ghanem, State University of New York at Buffalo
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
        • Contact:
          • Catherine Wrona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccination with Prevnar.
Intramuscular vaccination with Prevnar 20
Other: vaccine
Vaccination against 20 serotypes of S. pneumoniae

What is the study measuring?

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
Time Frame: 1 month
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
Time Frame: 1 month
Phenotype will be determined by measuring the expression of surface receptors on neutrophils ex vivo by flowcytometry from donors
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Elsa N Bou Ghanem, PhD, University at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007111
  • R01AG068568 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe