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

NCT06128915 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY00007111R01AG068568
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Aging; Neutrophils; Streptococcus pneumoniae; Pneumococcal conjugate vaccine

Outcome Measures

Primary Outcomes (1)

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

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

  1 month

Secondary Outcomes (1)

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

  1 month

Study Arms (1)

Vaccination with Prevnar.

EXPERIMENTAL

Intramuscular vaccination with Prevnar 20

Other: vaccine

Interventions

vaccine OTHER

Vaccination against 20 serotypes of S. pneumoniae

Vaccination with Prevnar.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Elsa N Bou Ghanem, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elsa Bou Ghanem, PhD

CONTACT

7168292422; elsaboug@buffalo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Enrolled participants will be assigned a unique study identification number followed by a visit number (example 1.1 for donor #1-first visit). The code list, linking patient identities (such as names/phone numbers) and samples, will be kept in a separate file locked in a drawer the PI's office. The code list and code-identified data will be stored in separate locations and only authorized individuals will have access to the list. Experiments and data analysis will be performed only on coded samples and researchers will only have access to the visit number as the experiments to be performed on the collected samples pre and post vaccination differ.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Vaccination with Prevnar.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 13, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)