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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128915
• Other study ID #: STUDY00007111
• Secondary ID: R01AG068568
• Status: Recruiting
• Phase: Phase 4
• Start date: January 8, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: February 2024
• Source: State University of New York at Buffalo
• Contact: Elsa Bou Ghanem, PhD
• Phone: 7168292422
• Email: elsaboug[@]buffalo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• vaccine
Vaccination against 20 serotypes of S. pneumoniae

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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