Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202703
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-05-23
Brief Title:
Fine Needle aSpiration of Lymph nodEs to Study vAccine-induced Immunity
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Optimisation of Lymph Node Fine Needle Aspiration to Study Pneumococcal Vaccine-induced Immunity
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEA
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 clinically effective in preventing invasive pneumococcal disease but the underlying immune response is likely to differ due to the inclusion of T cell epitopes in the conjugate but not purified polysaccharide vaccine However these differences remain scantly studied Lymph node fine needle aspiration FNA has been recently described to study vaccine-induced germinal centre responses in depth and represents a promising tool to study the underlying immune mechanisms of pneumococcal vaccines Insight into the underlying immune mechanisms of vaccines could improve future vaccine design eg by refining dosing intervals
Objective Determine timing of peak germinal centre B cell frequency following pneumococcal vaccination
Main trial endpoints The main trial endpoint is represented by the frequency of germinal centre B cells BGC in lymph node aspirates at various time points after vaccination as measured by spectral flow cytometry Both total BGC cells and S pneumoniae polysaccharide-specific BGC frequencies will be determined
Trial design Pilot intervention study without a comparator
Trial population Healthy individuals between the age of 20 - 40
Interventions Subjects will be vaccinated once with Prevenar13 FNA of the draining lymph node will be performed and blood will be drawn at baseline followed by weekly collection during the first four weeks every other week between weeks 4 - 8 and a final collection time point after 12 weeks resulting in a total of 8 sampling time points over the course of three months Draining lymph node size will be assessed by ultrasound every other day during the first two weeks and then alongside lymph node FNA for the remainder of the study
Objective Determine timing of peak germinal centre B cell frequency following pneumococcal vaccination
Main trial endpoints The main trial endpoint is represented by the frequency of germinal centre B cells BGC in lymph node aspirates at various time points after vaccination as measured by spectral flow cytometry Both total BGC cells and S pneumoniae polysaccharide-specific BGC frequencies will be determined
Trial design Pilot intervention study without a comparator
Trial population Healthy individuals between the age of 20 - 40
Interventions Subjects will be vaccinated once with Prevenar13 FNA of the draining lymph node will be performed and blood will be drawn at baseline followed by weekly collection during the first four weeks every other week between weeks 4 - 8 and a final collection time point after 12 weeks resulting in a total of 8 sampling time points over the course of three months Draining lymph node size will be assessed by ultrasound every other day during the first two weeks and then alongside lymph node FNA for the remainder of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None