AgingPhase 4NCT06128915
The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses
A Phase 4 study testing vaccine in people with Aging, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 31 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Known chronic infections
- Poorly controlled chronic cardiovascular and metabolic conditions
- Pregnancy
- Dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo
Buffalo, New York, 14203
Catherine Wrona
About this study
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.
Read the 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
- Conditions
- Aging
- Being tested
- vaccine
- Keywords
- Aging, Neutrophils, Streptococcus pneumoniae, Pneumococcal conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccineOther
Vaccination against 20 serotypes of S. pneumoniae
| Study group | Role | What they receive |
|---|---|---|
| Vaccination with Prevnar. | Experimental | Intramuscular vaccination with Prevnar 20 Receives: Other: vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start8 Jan 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Vaccination with Prevnar.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Elsa Bou Ghanem, State University of New York at Buffalo
- Investigators
- Elsa N Bou Ghanem, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128915
- Sponsor's protocol ID
- STUDY00007111
- Other IDs
- R01AG068568
- Status last verified
- Apr 2026
- First submitted
- 30 Oct 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses
- ClinicalTrials.gov ID
- NCT06128915
- Acronym / sponsor ID
- STUDY00007111
- Conditions
- Aging
- Keywords
- Aging, Neutrophils, Streptococcus pneumoniae, Pneumococcal conjugate vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Vaccination with Prevnar.
| Arm | Type | Receives |
|---|---|---|
| Vaccination with Prevnar. | Experimental | Other: vaccineIntramuscular vaccination with Prevnar 20 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaccineVaccination against 20 serotypes of S. pneumoniae | Other | Vaccination with Prevnar. |
Primary outcome
Pneumococcal Opsonophagocytic Killing Activity (OPH) by neutrophils from young versus old donors at 1 week and 1 month after vaccination
Time frame: 1 month
OPH will be determined by measuring the percentage of S. pneumoniae bacteria killed in vitro by neutrophils from donors
1 secondary outcome
Surface phenotype of neutrophils from young versus old donors at 1 week and 1 month after vaccination
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elsa N Bou Ghanem, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vaccine in people with Aging, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elsa Bou Ghanem, PhD (7168292422, elsaboug@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumococcal Opsonophagocytic Killing Activity (OPH) by neutrophils from young versus old donors at 1 week and 1 month after vaccination (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.