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Using lymph nOde fine needle aspiration to assess the effeCt of pnEumococcal vAcciNe platform, Age and HIV infection on Germinal cEntre formation (OCEAN-AGE)

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510354-16-00
Acronym
2023-510354-16-00
Enrollment
75
Registered
2025-01-27
Start date
2025-03-06
Completion date
Unknown
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection

Brief summary

Immunophenotyping of lymph node FNA samples (% germinal centre B cells and %T follicular helper cells), 4 weeks after vaccination.

Detailed description

Immunophenotyping of PBMC's 6 months after vaccination (% S. pneumoniae PS-specific B cells per serotype, Spn PS-specific B cell phenotype, Spn PS-specific antibody titres, Spn PS-specific antibody fuctionality, CRM-197 specific B cells and T cells., Serum and lymph node supernatant biomarkers at day 7, day 28 and day 72 post vaccination, Immunophenotyping and functional analysis of PBMCs at baseline, Serum biomarkers at baseline., Pneumococcal serotype specific colonisation in saliva, lymph node size in cortical thickness, long axis and short axis (determined by ultrasound), Comparing Spn PS-specific antibody titres in saliva to Spn PS-specific antibody titres in peripheral blood., Association between diet, excercise, alcohol consumption, smoking, comorbidities, medication, clinical Frailty score, CD4+ T cell count and immune response (% Bgc cells and Tfh cells, 4 weeks after vaccination)., Pneumococcal serotype specific colonisation in saliva and its association with post vaccination serotype specific B cells, serotype specific antibody response and OPA-titres in peripheral blood.

Interventions

DRUGadsorbed)
DRUGPNEUMOVAX 23 ενέσιμο διάλυμα σε προγεμισμένη σύριγγαΠολυσακχαριδικό Εμβόλιο Πνευμονιόκοκκου

Sponsors

Academisch Ziekenhuis Leiden
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Immunophenotyping of lymph node FNA samples (% germinal centre B cells and %T follicular helper cells), 4 weeks after vaccination.

Secondary

MeasureTime frame
Immunophenotyping of PBMC's 6 months after vaccination (% S. pneumoniae PS-specific B cells per serotype, Spn PS-specific B cell phenotype, Spn PS-specific antibody titres, Spn PS-specific antibody fuctionality, CRM-197 specific B cells and T cells., Serum and lymph node supernatant biomarkers at day 7, day 28 and day 72 post vaccination, Immunophenotyping and functional analysis of PBMCs at baseline, Serum biomarkers at baseline., Pneumococcal serotype specific colonisation in saliva, lymph node size in cortical thickness, long axis and short axis (determined by ultrasound), Comparing Spn PS-specific antibody titres in saliva to Spn PS-specific antibody titres in peripheral blood., Association between diet, excercise, alcohol consumption, smoking, comorbidities, medication, clinical Frailty score, CD4+ T cell count and immune response (% Bgc cells and Tfh cells, 4 weeks after vaccination)., Pneumococcal serotype specific colonisation in saliva and its association with post vaccination

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026