Pneumococcal vaccine response in lymph nodes

2022-501519-15-00 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 1 Apr 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 5
Countries 1
Sites 1

Healthy volunteers

Determine timing of peak germinal center B cell frequency in lymph node aspirates

Key facts

Sponsor
Leiden University Medical Center
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Phenomena and Processes [G] - Immune system processes [G12], Phenomena and Processes [G] - Immune System Phenomena [G13], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Trial duration
1 Apr 2023 → ongoing
Decision date (initial)
2023-02-02
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
LUMC

External identifiers

EU CT number
2022-501519-15-00
WHO UTN
U1111-1285-0005

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Determine timing of peak germinal center B cell frequency in lymph node aspirates

Secondary objectives 6

  1. Determine timing of peak T follicular helper cell frequency in lymph node aspirates
  2. Assess phenotypic changes of B cells and T cells over time in lymph node aspirates
  3. Identify peripheral blood cell types/phenotype correlating with germinal center reaction
  4. Identify peripheral blood biomarkers correlating with germinal center reaction (e.g. serologic response, CXCL-13)
  5. Evaluate changes in the lymph node microenvironment
  6. Evaluate differential response kinetics between primary vaccination and booster vaccination

Conditions and MedDRA coding

Healthy volunteers

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Participants between the ages of 20 and 40 years old
  2. 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 10

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Percentage of (polysaccharide-specific) germinal centre B cells in lymph node aspirates, as determined by spectral flow cytometry

Secondary endpoints 5

  1. Kinetics of the proportion of T follicular helper cells in lymph node aspirates
  2. Dynamics in B cell and T cell phenotype in lymph node aspirates, including immunoglobulin class switching and activation/differentiation markers
  3. Deep immunophenotyping of B cells and T cells in peripheral blood by spectral flow cytometry
  4. Timing of seroconversion in peripheral blood
  5. Cytokine concentration in peripheral blood and lymph node aspirate

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Apexxnar suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)

PRD9493438 · Product

Active substance
Pneumococcal Polysaccharide Serotype 1 Conjugated to CRM197 Adsorbed on Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL02 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED
Marketing authorisation
EU/1/21/1612/001
MA holder
PFIZER EUROPE MA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Prevenar 13 suspension for injection in single dose vial pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

PRD1703872 · Product

Active substance
Pneumococcal Polysaccharide Serotype 1 Conjugated to CRM197 Adsorbed on Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL02 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED
Marketing authorisation
EU/1/09/590/010
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leiden University Medical Center

12 Total trials 5 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Leiden University Medical Center
Address
Albinusdreef 2
City
Leiden
Postcode
2333 ZA
Country
Netherlands

Scientific contact point

Organisation
Leiden University Medical Center
Contact name
Anna Roukens

Public contact point

Organisation
Leiden University Medical Center
Contact name
Anna Roukens

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruiting 5 1
Rest of world — 0 —

Investigational sites

Netherlands

1 site · Ongoing, recruiting
Leiden University Medical Center
Infectious Diseases, Albinusdreef 2, 2333 ZA, Leiden

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2023-04-01 2023-04-11

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-11-14 Netherlands Acceptable
2023-01-31
 2023-02-02
2 SUBSTANTIAL MODIFICATION SM-2 2024-03-28 Netherlands Acceptable
2024-06-20
 2024-06-20

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