Clinical trial • Phase IV • Infectious Disease

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 Chronic obstructive pulmonary disease (COPD)

Phase IV trial of PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CO…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Chronic obstructive pulmonary disease (COPD)
Trial Stage
Phase IV
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
01-09-2025
First CTIS Authorization Date
08-12-2025

Trial design

SALINE (SALINE solution for injection), intramuscular, 0.5 ml (placebo) - comparator/placebo arm indicated; comparator dosing: maxTotalDoseAmount 0.5 ml, route intramuscular.-controlled Phase IV trial across 1 site in Denmark.

Comparator
SALINE (SALINE solution for injection), intramuscular, 0.5 ml (placebo) - comparator/placebo arm indicated; comparator dosing: maxTotalDoseAmount 0.5 ml, route intramuscular.
Target Sample Size
60
Trial Duration For Participant
180

Eligibility

Recruits 60 No vulnerable population selected (isVulnerablePopulationSelected: false). Volunteers must sign informed consent (principal inclusion criterion and subject information / consent form documents listed). No assent/paediatric consent processes are indicated..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Volunteers must sign informed consent (principal inclusion criterion and subject information / consent form documents listed). No assent/paediatric consent processes are indicated.

Inclusion criteria

  • {"criterion_text":"- A confirmed COPD diagnosis by a respiratory medicine specialist requiring attention at the hospital's outpatient clinic\n- Age≥60 years\n- Previous PPV23 vaccination more than one year before inclusion\n- Volunteer agrees to participate in all aspects of the trial and has signed the informed consent."}

Exclusion criteria

  • {"criterion_text":"- Immunocompromised status (primary, or secondary immunodeficiencies e.g., HIV, cancer therapy chemo, any medications that would suppress the immune system)\n- Receipt of any PCV or RSV vaccine at any time\n- Acute illness within the previous 14 days (including COPD exacerbations and fever)\n- Receipt of any other vaccine within the last four weeks\n- Allergens towards one of the ingredients in the trial medication.\n- Previous illness with Gullain-Barré syndrome."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Interferon-gamma (IFN-γ) Response. Measured as the increase in systemic IFN-γ levels at 24 hours post-vaccination compared to baseline.","definition_or_measurement_approach":"Measured as the increase in systemic IFN-γ levels at 24 hours post-vaccination compared to baseline (systemic IFN-γ levels, 24 hours vs baseline)."}

Secondary endpoints

  • {"endpoint_text":"- NK Cell Activation. Change in Natural Killer (NK) cell activation markers (e.g., CD69 expression) 24 hours post-vaccination compared to baseline.","definition_or_measurement_approach":"Change in NK cell activation markers (e.g., CD69 expression) measured 24 hours post-vaccination compared to baseline."}
  • {"endpoint_text":"- Gene Signature of Innate Activation. The expression levels of a predefined set of genes associated with the interferon response (e.g., IRF7, IFIT1) measured via transcriptomic analysis of peripheral blood mononuclear cells (PBMCs) pre- and post-vaccination.","definition_or_measurement_approach":"Transcriptomic analysis of PBMCs measuring expression levels of a predefined interferon-response gene set (e.g., IRF7, IFIT1) pre- and post-vaccination."}
  • {"endpoint_text":"- Pneumococcal-Specific IgG Antibody Titers and Functional activity a. Increase in IgG GMCs for 12 pneumococcal serotypes included in PCV20, measured 30 days and 180 days post-vaccination. b. Assessment of functional pneumococcal antibodies through OPA for key serotypes, including serotype 3, at 30- and 180-day post-vaccination. c. Antibody glycosylation analysis (sialylation/desialylation), at 30- and 180-day post-vaccination","definition_or_measurement_approach":"a) Geometric mean concentrations (GMCs) of IgG for 12 PCV20 serotypes at 30 and 180 days post-vaccination; b) Opsonophagocytic assay (OPA) for key serotypes (including serotype 3) at 30 and 180 days; c) Antibody glycosylation (sialylation/desialylation) analysis at 30 and 180 days."}
  • {"endpoint_text":"- CD4+ T-cell Responses. Quantification of polyfunctional CD4+ T-cell responses (Th1-biased), as assessed by cytokine production (IFN-γ, TNF-α, IL-2) following ex vivo stimulation with RSV and pneumococcal antigens.","definition_or_measurement_approach":"Quantification of polyfunctional Th1-biased CD4+ T-cell responses by measuring cytokine production (IFN-γ, TNF-α, IL-2) after ex vivo stimulation with RSV and pneumococcal antigens."}
  • {"endpoint_text":"- RSV antibody titers. RSV pre-F-binding antibody titers will be quantified on samples obtained on days 0, 30, and 180","definition_or_measurement_approach":"Measurement of RSV pre-F-binding antibody titers on samples collected at days 0, 30, and 180."}
  • {"endpoint_text":"- CD4 Responses. Directed against RSV and the conjugate protein of the pneumococcal vaccine.","definition_or_measurement_approach":"Assessment of CD4 T-cell responses directed against RSV and the pneumococcal conjugate protein (method not further specified in the provided text)."}

Recruitment

Planned Sample Size
60
Recruitment Window Months
28
Consent Approach
Volunteers must sign informed consent (principal inclusion criterion). Subject information and informed consent form documents are provided (documents titled 'Deltagerinformation', 'Samtykkerklring', etc.). No paediatric assent processes or languages specified in the provided data.

Geography

Total Number Of Sites
1
Total Number Of Participants
60

Denmark

Earliest CTIS Part Ii Submission Date
04-12-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
4
Number Of Sites
1
Number Of Participants
60

Sites

Site Name
Nordsjaellands Hospital
Department Name
Departement of respiratory and infectious diseases
Principal Investigator Name
Zitta Barrella Harboe
Principal Investigator Email
zitta.barrella.harboe@regionh.dk
Contact Person Name
Zitta Barrella Harboe
Number Of Participants
60

Sponsor

Primary sponsor

Full Name
Nordsjaellands Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

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
Authorised (marketing authorisation EU/1/21/1612/001)
Starting Dose
0.5 ml
Maximum Dose
0.5 ml
Investigational Product Name
Arexvy powder and suspension for suspension for injection Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)
Active Substance
RESPIRATORY SYNCYTIAL VIRUS, GLYCOPROTEIN F, RECOMBINANT, STABILISED IN THE PRE-FUSION CONFORMATION, ADJUVANTED WITH AS01E
Modality
Vaccine
Routes Of Administration
INTRAMUSCULAR
Route
Intramuscular
Authorisation Status
Authorised (marketing authorisation EU/1/23/1740/001)
Starting Dose
0.5 ml
Maximum Dose
0.5 ml
Investigational Product Name
SALINE
Active Substance
SALINE
Modality
Other
Routes Of Administration
INTRAMUSCULAR
Route
Intramuscular
Starting Dose
0.5 ml
Maximum Dose
0.5 ml
Combination Treatment
Yes

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