Status:
RECRUITING
Fine Needle aSpiration of Lymph nodEs to Study vAccine-induced Immunity
Lead Sponsor:
Leiden University Medical Center
Conditions:
Vaccine-Preventable Diseases
Eligibility:
All Genders
20-40 years
Phase:
NA
Brief Summary
Rationale Causing a wide range of infectious diseases, including pneumonia, otitis media and meningitis, S. pneumoniae represents an important global health problem. Pneumococcal vaccines are clinical...
Eligibility Criteria
Inclusion
- Participants between the ages of 20 and 40 years old
- Participants should be generally healthy and without substantial co-morbidities, 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 enrollment, might be eligible for this study.
Exclusion
- BMI \> 30 kg/m2
- Pregnancy at time of inclusion
- Breastfeeding during the course of the study
- Documented pneumococcal vaccination and/or infection
- Pneumococcal infection is defined as any infection that is microbiologically confirmed to be caused by S. pneumoniae (e.g. positive blood or sputum cultures for S. pneumoniae, positive urine S. pneumoniae antigen test)
- 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
- Vaccination with any vaccine \< 1 month before inclusion
- Subjects vaccinated 1 - 6 months before enrolment can be included into the study. Study vaccine will be injected in the contralateral arm.
- Fever at time of inclusion
Key Trial Info
Start Date :
April 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06202703
Start Date
April 15 2023
End Date
October 15 2024
Last Update
January 11 2024
Active Locations (1)
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1
Leiden University Medical Center
Leiden, Netherlands, 2333ZA