Vaccine-Preventable DiseasesSEANCT06202703
Fine Needle aSpiration of Lymph nodEs to Study vAccine-induced Immunity
A study testing Pneumococcal Vaccine in people with Vaccine-Preventable Diseases, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine-Preventable Diseases
- What is being tested?
- Pneumococcal Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Apr 2023to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333ZA
Anna H Roukens, MD, PhD, +31715262613, a.h.e.roukens@lumc.nl
Leo G Visser, MD, PhD, +31715262613, l.g.visser@lumc.nl
About this study
Official title: Optimisation of Lymph Node Fine Needle Aspiration to Study Pneumococcal Vaccine-induced Immunity
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, e.g. by refining dosing intervals.
Objective Determine timing of peak germinal centre B cell frequency following pneumococcal vaccination.
Read more
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.
- Conditions
- Vaccine-Preventable Diseases
- Being tested
- Pneumococcal Vaccine
- Medical subject headings
- Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal VaccineDrug
Also called vaccine with pneumococcal polysaccharides of 13 different serotypes conjugated to a protein (Prevnar13)
vaccination with pneumococcal vaccine (PCV13)
| Study group | Role | What they receive |
|---|---|---|
| pneumococcal vaccination arm | Experimental | the participants will receive a registered pneumococcal vaccine according to manufacturers instructions Receives: Drug: Pneumococcal Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak germinal center B cell count
frequency of germinal centre B cells (BGC) in lymph node aspirates will be measured at various time points after vaccination, as measured by spectral flow cytometry. Lymph node sampling will take place every week for the first 4 weeks, than every other week until week 8. Characterization of the lymphocytes in the lymph node aspirate will be performed by flow cytometry
Measured: 3 months
Secondary outcomes (1)
immune analysis of lymph node aspirates after pneumococcal vaccination
In addition to evaluating the frequency of (antigen-specific) BGC cells (outcome 1), we will perform phenotyping of these cells. Phenotyping includes measurement of activation markers, immunoglobulin class switching and markers associated with B cell differentiation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Apr 2023
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine-Preventable DiseasesStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna HE Roukens, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202703
- Sponsor's protocol ID
- U1111-1285-0005
- Acronym
- SEA
- Status last verified
- Jan 2024
- First submitted
- 23 May 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will share data under restricted access, this is out institution's policy
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Lymph Node Fine Needle Aspiration to Study Pneumococcal Vaccine-induced Immunity
- ClinicalTrials.gov ID
- NCT06202703
- Acronym / sponsor ID
- SEA / U1111-1285-0005
- Conditions
- Vaccine-Preventable Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
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, e.g. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pneumococcal vaccination arm | Experimental | Drug: Pneumococcal Vaccinethe participants will receive a registered pneumococcal vaccine according to manufacturers instructions |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| Pneumococcal VaccineAlso: vaccine with pneumococcal polysaccharides of 13 different serotypes conjugated to a protein (Prevnar13)vaccination with pneumococcal vaccine (PCV13) | Drug | pneumococcal vaccination arm |
Primary outcome
peak germinal center B cell count
Time frame: 3 months
frequency of germinal centre B cells (BGC) in lymph node aspirates will be measured at various time points after vaccination, as measured by spectral flow cytometry. Lymph node sampling will take place every week for the first 4 weeks, than every other week until week 8. Characterization of the lymphocytes in the lymph node aspirate will be performed by flow cytometry
1 secondary outcome
immune analysis of lymph node aspirates after pneumococcal vaccination
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No. we will share data under restricted access, this is out institution's policy
Related trials for Vaccine-Preventable Diseases
Recruiting
The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
Hepatitis B, Vaccination; Infection
Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
Active, not recruitingPhase 1/2
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
Shingles, Herpes Zoster
RecruitingPhase 4
Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania
HPV Infection, Vaccine Preventable Disease
Active, not recruitingObservational study
Herpes Virus Infections in Kidney Transplant Patients
Kidney Transplant; Complications, Varicella Zoster Virus Infection
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumococcal Vaccine in people with Vaccine-Preventable Diseases, run by Leiden University Medical Center at 1 site in Netherlands.
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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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 Netherlands. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna H Roukens, MD, PhD (+31715262613, a.h.e.roukens@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak germinal center B cell count (time frame: 3 months). 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 11 Jan 2024.