Recruiting

Observational Study

Sponsor:

State University of New York at Buffalo

Code:

NCT06128915

Conditions

Aging

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

vaccine

Study Details

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

Study ID

NCT06128915

Start date

Jan 8, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Vaccination with Prevnar.

Intramuscular vaccination with Prevnar 20

Interventions

vaccine

Vaccination against 20 serotypes of S. pneumoniae

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Elsa Bou Ghanem, PhD

7168292422elsaboug@buffalo.edu

Locations

University at Buffalo

Recruiting

Buffalo, New York, United States, 14203

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Apr 3, 2026

Last verified

Apr, 2026

Keywords

  • Aging
  • Neutrophils
  • Streptococcus pneumoniae
  • Pneumococcal conjugate vaccine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-04-03.