The Role of Neutrophils in the Age-driven Decline in Anti... | NCT06128915

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

NCT06128915

Sponsor

State University of New York at Buffalo

Status

Recruiting

Last Update Posted

Apr 3, 2026Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Aging

Interventions

vaccine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AG068568	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2024Actual

Primary Completion Date

May 31, 2027Estimated

Completion Date

May 31, 2027Estimated

First Submitted Date

Oct 30, 2023

First Submission Date that Met QC Criteria

Nov 8, 2023

First Posted Date

Nov 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 3, 2026Actual

Name	Class
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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:

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccination with Prevnar.	Experimental	Intramuscular vaccination with Prevnar 20	Other: vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vaccine	Other	Vaccination against 20 serotypes of S. pneumoniae	Vaccination with Prevnar.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Surface phenotype of neutrophils from young versus old donors at 1 week and 1 month after vaccination	Phenotype will be determined by measuring the expression of surface receptors on neutrophils ex vivo by flowcytometry from donors	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elsa Bou Ghanem, PhD	Contact	7168292422		elsaboug@buffalo.edu

Overall Officials

Name	Affiliation	Role
Elsa N Bou Ghanem, PhD	University at Buffalo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University at Buffalo	Recruiting	Buffalo	New York	14203	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D014612	Vaccines

ID	Term
D001688	Biological Products
D045424	Complex Mixtures

Masking Info

Masking

None (Open Label)

Masking Description

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.

Who Masked

Not provided