Clinical trial • Phase IV • Infectious Disease|Musculoskeletal
RESPIRATORY SYNCYTIAL VIRUS, GLYCOPROTEIN F, RECOMBINANT, STABILISED IN THE PRE-FUSION CONFORMATION, ADJUVANTED WITH AS01E for Inflammatory rheumatic disease|Rheumatoid arthritis|Psoriatic arthritis|Systemic lupus erythematosus|Juvenile arthritis|Giant cell arteritis|Polyarthritis|Polymyalgia rheumatica|Systemic necrotising vasculitis|Spondylarthritis
Phase IV trial of RESPIRATORY SYNCYTIAL VIRUS, GLYCOPROTEIN F, RECOMBINANT, STABILISED IN THE PRE-FUSION CONFORMATION, ADJUVANTED WITH AS01E for Inflammat…
Overview
- Trial Therapeutic Area
- Infectious Disease|Musculoskeletal
- Trial Disease
- Inflammatory rheumatic disease|Rheumatoid arthritis|Psoriatic arthritis|Systemic lupus erythematosus|Juvenile arthritis|Giant cell arteritis|Polyarthritis|Polymyalgia rheumatica|Systemic necrotising vasculitis|Spondylarthritis
- Trial Stage
- Phase IV
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 18-04-2025
- First CTIS Authorization Date
- 09-07-2025
Trial design
Immunocompetent control group (healthy volunteers) compared to inflammatory rheumatic disease patients on antirheumatic treatments Phase IV trial across 2 sites in Sweden.
- Comparator
- Immunocompetent control group (healthy volunteers) compared to inflammatory rheumatic disease patients on antirheumatic treatments
- Target Sample Size
- 180
Eligibility
Recruits 180 Vulnerable population not selected. Written informed consent required from participants; no assent or other vulnerable-population procedures specified..
- Vulnerable Population
- Vulnerable population not selected. Written informed consent required from participants; no assent or other vulnerable-population procedures specified.
Inclusion criteria
- {"criterion_text":"- The subject has given their written consent to participate in the trial.\n- Age ≥60 years.\n- Having regular follow-up at rheumatology department in Lund, Malmö or Kristianstad\n- Receiving immunomodulating treatment for at least 3 months (only for patients)"}
Exclusion criteria
- {"criterion_text":"- Immunodeficiency (not related to immunomodulating antirheumatic treatment)\n- Changes of immunomodulating treatment four weeks before the vaccination\n- Not willing to get vaccinated against RSV\n- Prior vaccination against RSV\n- Fever or ongoing infection\n- Hypersensitivity to the active substances or to any of the excipients of both RSV vaccines (Abrysvo and Arexvy)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Antibody response, i.e. fold-change of RSVpreF-specific IgG antibody level from pre- to post-vaccination (3-6 weeks).","definition_or_measurement_approach":"Fold-change in RSVpreF-specific IgG antibody level measured pre-vaccination and at 3-6 weeks post-vaccination."}
Secondary endpoints
- {"endpoint_text":"- Functional RSVpreF-antigen specific T-cell response.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Reported adverse events.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 180
- Recruitment Window Months
- 26
- Consent Approach
- Written informed consent required from each participant ('The subject has given their written consent to participate in the trial.'). Participant information/informed consent documents provided (document titles in Swedish: 'Information till forsoksperson' and 'Information till forsoksperson friska kontroller'). No assent or age-specific consent procedures described.
Methods
- Recruitment of patients from rheumatology departments with regular follow-up in Lund, Malmö or Kristianstad (Sweden); investigators at participating hospitals (contact emails provided) to approach eligible patients and healthy volunteers.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 180
Sweden
- Earliest CTIS Part Ii Submission Date
- 19-06-2025
- Latest Decision Or Authorization Date
- 09-07-2025
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 180
Sites
- Site Name
- Region Skane Kristianstad Central Hospital
- Department Name
- Infectious diseases
- Principal Investigator Name
- Per Nived
- Principal Investigator Email
- per.nived@med.lu.se
- Contact Person Name
- Per Nived
- Contact Person Email
- per.nived@med.lu.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Rheumatology
- Principal Investigator Name
- Meliha C. Kapetanovic
- Principal Investigator Email
- meliha.c_kapetanovic@med.lu.se
- Contact Person Name
- Meliha C. Kapetanovic
- Contact Person Email
- meliha.c_kapetanovic@med.lu.se
Sponsor
Primary sponsor
- Full Name
- Region Skane
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- 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 INJECTION
- Route
- Intramuscular injection
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: EU/1/23/1740/002)
- Starting Dose
- 0.5 ml
- Frequency
- Single dose
- Maximum Dose
- 0.5 ml
- Investigational Product Name
- Abrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent, recombinant)
- Active Substance
- RESPIRATORY SYNCYTIAL VIRUS, SUBGROUP A, STABILIZED PREFUSION F PROTEIN 847A; RESPIRATORY SYNCYTIAL VIRUS, SUBGROUP B, STABILIZED PREFUSION F PROTEIN 847B
- Modality
- Vaccine
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- Intramuscular injection
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: EU/1/23/1752/005)
- Starting Dose
- 0.5 ml
- Frequency
- Single dose
- Maximum Dose
- 0.5 ml
Related trials
Other published trials that may interest you.