Clinical trial • Phase I • Immunology
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE for HIV infection
Phase I trial of PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSA…. CTIS 2023-510354-16-00.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- HIV infection
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 03-10-2024
- First CTIS Authorization Date
- 27-01-2025
Trial design
Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) — 0.5 ml intramuscular (test); PNEUMOVAX 23 solution for injection in pre-filled syringe — 0.5 ml intramuscular (comparator).-controlled Phase I trial across 1 site in Netherlands.
- Comparator
- Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) — 0.5 ml intramuscular (test); PNEUMOVAX 23 solution for injection in pre-filled syringe — 0.5 ml intramuscular (comparator).
- Target Sample Size
- 75
- Trial Duration For Participant
- 182
Eligibility
Recruits 75 No vulnerable populations selected. Exclusion criterion includes: 'Inability to provide informed consent'. Participants must be able to provide informed consent; no assent arrangements for minors or other vulnerable groups are described..
- Pregnancy Exclusion
- Pregnancy at time of inclusion
- Vulnerable Population
- No vulnerable populations selected. Exclusion criterion includes: 'Inability to provide informed consent'. Participants must be able to provide informed consent; no assent arrangements for minors or other vulnerable groups are described.
Inclusion criteria
- {"criterion_text":"- Age between 20 - 40 years or age > 60 years.\n- Generally Healthy\n- For PLWH group: aged 20 - 40 years, with documented HIV infection on active anti-retroviral therapy resulting in viral supression ( HIV copies < 200/ml)"}
Exclusion criteria
- {"criterion_text":"- Pregnancy at time of inclusion\n- Use of immunosuppressive medication\n- Use of direct acting anticoagulant drugs (DOACs) or vitamin K antagonists\n- Known hypersensitivity to vaccine components\n- Recent (past month) surgery in axillar area or major surgery elsewhere\n- Chronic nasal corticosteroid use (> 3 months)\n- History of severe nose bleeds\n- Vaccination < 1 month before inclusion\n- Fever at time of inclusion\n- Inability to provide informed consent\n- Inability to visit the LUMC for study procedures.\n- Breastfeeding during the course of the study\n- Prior documented pneumococcal vaccination\n- Prior pneumococcal infection\n- Documented primary immune disorder or primary coagulopathy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Immunophenotyping of lymph node FNA samples (% germinal centre B cells and %T follicular helper cells), 4 weeks after vaccination.","definition_or_measurement_approach":"Immunophenotyping performed on lymph node fine needle aspiration (FNA) samples measuring % germinal centre B cells and % T follicular helper cells at 4 weeks post-vaccination."}
Secondary endpoints
- {"endpoint_text":"- Immunophenotyping of PBMC's 6 months after vaccination (% S. pneumoniae PS-specific B cells per serotype, Spn PS-specific B cell phenotype, Spn PS-specific antibody titres, Spn PS-specific antibody fuctionality, CRM-197 specific B cells and T cells.\n- Serum and lymph node supernatant biomarkers at day 7, day 28 and day 72 post vaccination\n- Immunophenotyping and functional analysis of PBMCs at baseline\n- Serum biomarkers at baseline.\n- Pneumococcal serotype specific colonisation in saliva\n- lymph node size in cortical thickness, long axis and short axis (determined by ultrasound)\n- Comparing Spn PS-specific antibody titres in saliva to Spn PS-specific antibody titres in peripheral blood.\n- Association between diet, excercise, alcohol consumption, smoking, comorbidities, medication, clinical Frailty score, CD4+ T cell count and immune response (% Bgc cells and Tfh cells, 4 weeks after vaccination).\n- Pneumococcal serotype specific colonisation in saliva and its association with post vaccination serotype specific B cells, serotype specific antibody response and OPA-titres in peripheral blood.","definition_or_measurement_approach":"Measures include immunophenotyping of PBMCs (including serotype-specific B cells and phenotypes), antibody titres and functionality, CRM-197 specific cellular responses, biomarker assays in serum and lymph node supernatant at specified days (day 7, 28 and day 72), ultrasound measurement of lymph node dimensions, saliva pneumococcal colonisation assessments, and association analyses with clinical/demographic factors; PBMC immunophenotyping timepoint includes a 6-month post-vaccination assessment."}
Recruitment
- Planned Sample Size
- 75
- Recruitment Window Months
- 24
- Consent Approach
- Participants must provide informed consent; exclusion includes 'Inability to provide informed consent'. A subject information and informed consent form document is listed (L1_Subject information sheet 2023-510354-16-00 NL_Redacted). No assent procedures or additional consent handling for vulnerable populations are described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 75
Netherlands
- Earliest CTIS Part Ii Submission Date
- 10-01-2025
- Latest Decision Or Authorization Date
- 31-01-2025
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 75
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Anna Roukens
- Principal Investigator Email
- a.h.e.roukens@lumc.nl
- Contact Person Name
- Anna Roukens
- Contact Person Email
- a.h.e.roukens@lumc.nl
- Number Of Participants
- 75
Sponsor
Primary sponsor
- Full Name
- Academisch Ziekenhuis Leiden
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
- Active Substance
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
- Modality
- Vaccine
- Routes Of Administration
- Intramuscular
- Route
- Intramuscular
- Authorisation Status
- Marketing-authorised (marketingAuthNumber: EU/1/21/1612/001)
- Starting Dose
- 0.5 ml
- Dose Levels
- 0.5 ml
- Frequency
- Single vaccination
- Maximum Dose
- 2 ml
- Investigational Product Name
- PNEUMOVAX 23 ενέσιμο διάλυμα σε προγεμισμένη σύριγγαΠολυσακχαριδικό Εμβόλιο Πνευμονιόκοκκου (PNEUMOVAX 23)
- Active Substance
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A
- Modality
- Vaccine
- Routes Of Administration
- Intramuscular
- Route
- Intramuscular
- Authorisation Status
- Marketing-authorised (marketingAuthNumber: 22971)
- Starting Dose
- 0.5 ml
- Dose Levels
- 0.5 ml
- Frequency
- Single vaccination
- Maximum Dose
- 0.5 ml
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