Pneumococcal vaccine response in lymph nodes

Phase 1

Recruiting

Conditions: Healthy volunteers
Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]
Therapeutic area: Phenomena and Processes [G] - Immune System Phenomena [G13]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Registration Number: CTIS2022-501519-15-00

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 5

Inclusion Criteria

Participants between the ages of 20 and 40 years old, Participants should be generally healthy and without substantial comorbidities, including all auto-immune diseases that are being actively treated with immunosuppressive therapy. Patients with chronic diseases that do not require immunosuppressive therapy and are stable, defined as not requiring change of therapy or hospitalization in the six weeks preceding study enrolment, might be eligible for this study.

Exclusion Criteria

Subject has a BMI > 30, Breastfeeding during the course of the study, Documented pneumococcal vaccination and/or infection, Documented HIV infection, Documented primary immune disorder or primary coagulopathy, Use of immunosuppressive medication or anticoagulants, Known hypersensitivity to any of the vaccine components, Recent (i.e. <4 weeks before inclusion) surgery in axillar area or major surgery elsewhere, Fever at time of inclusion, Pregnancy at time of inclusion

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine timing of peak germinal center B cell frequency in lymph node aspirates;Secondary Objective: Determine timing of peak T follicular helper cell frequency in lymph node aspirates, Assess phenotypic changes of B cells and T cells over time in lymph node aspirates, Identify peripheral blood cell types/phenotype correlating with germinal center reaction, Identify peripheral blood biomarkers correlating with germinal center reaction (e.g. serologic response, CXCL-13), Evaluate changes in the lymph node microenvironment, Evaluate differential response kinetics between primary vaccination and booster vaccination;Primary end point(s): Percentage of (polysaccharide-specific) germinal centre B cells in lymph node aspirates, as determined by spectral flow cytometry

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Kinetics of the proportion of T follicular helper cells in lymph node aspirates;Secondary end point(s):Dynamics in B cell and T cell phenotype in lymph node aspirates, including immunoglobulin class switching and activation/differentiation markers;Secondary end point(s):Deep immunophenotyping of B cells and T cells in peripheral blood by spectral flow cytometry;Secondary end point(s):Timing of seroconversion in peripheral blood;Secondary end point(s):Cytokine concentration in peripheral blood and lymph node aspirate