Clinical trial NCT06128915: The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses
Official title: The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Aging
Keywords: Aging
Neutrophils
Streptococcus pneumoniae
Pneumococcal conjugate vaccine
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Vaccination with Prevnar.
Primary purpose: BASIC_SCIENCE

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:

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

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

Primary outcomes:
measure: Pneumococcal Opsonophagocytic Killing Activity (OPH) by neutrophils from young versus old donors at 1 week and 1 month after vaccination
timeFrame: 1 month
Secondary outcomes:
measure: Surface phenotype of neutrophils from young versus old donors at 1 week and 1 month after vaccination
timeFrame: 1 month
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Elsa N Bou Ghanem, PhD
role: PRINCIPAL_INVESTIGATOR
References: