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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Vaccination with Prevnar.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

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.

Study Groups

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Vaccination with Prevnar.

Intramuscular vaccination with Prevnar 20

Group Type EXPERIMENTAL

vaccine

Intervention Type OTHER

Vaccination against 20 serotypes of S. pneumoniae

Interventions

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vaccine

Vaccination against 20 serotypes of S. pneumoniae

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes