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

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06128915
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 60
• Arm: 1
• Anticipated Duration (Months): 28.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Other: vaccine	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Vaccination with Prevnar.Vaccination with Prevnar.
• 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.
• Primary Purpose: Basic Science
• Official Title: The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses
• Anticipated Study Start Date: Jan 8, 2024
• Anticipated Primary Completion Date: May 1, 2026
• Anticipated Study Completion Date: May 31, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

   Phenotype will be determined by measuring the expression of surface receptors on neutrophils ex vivo by flowcytometry from donors

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elsa Bou Ghanem, Principal Investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT06128915
• Other Study ID Numbers: STUDY00007111; R01AG068568
• First Posted: Nov 13, 2023
• Last Update Posted: Nov 13, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Elsa Bou Ghanem, Principal Investigator, State University of New York at Buffalo: Aging; Neutrophils; Streptococcus pneumoniae; Pneumococcal conjugate vaccine

Study Results

No Results Posted as of Nov 13, 2023