Vaccination against respiratory syncytial virus in patients with inflammatory rheumatic diseases. The impact of anti-rheumatic treatments on the RSV immune response.

2024-518191-31-00 Protocol RSV-REUMA Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol RSV-REUMA

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 180
Countries 1
Sites 2

Inflammatory rheumatic disease

The primary objective of this trial is to assess if immunomodulating antirheumatic treatments including synthetic disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate and different biological treatments (anti-TNF, anti IL6r, anti-IL12/23/17, anti-CD20, anti-BlyS, or targeted DMARDs (JAK-inhibitors)) imp…

Key facts

Sponsor
Region Skane
Participant type
Healthy volunteers, Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Virus Diseases [C02], Diseases [C] - Musculoskeletal Diseases [C05]
Decision date (initial)
2025-07-09
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Prophylaxis

The primary objective of this trial is to assess if immunomodulating antirheumatic treatments including synthetic disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate and different biological treatments (anti-TNF, anti IL6r, anti-IL12/23/17, anti-CD20, anti-BlyS, or targeted DMARDs (JAK-inhibitors)) impair the humoral immune response to one dose of RSV vaccine in IRD patients compared to immunocompetent controls.

Secondary objectives 2

  1. To assess if immunomodulating antirheumatic treatments impair the cell-mediated immune response to one dose of RSV vaccine in IRD patients compared to immunocompetent controls.
  2. To assess the safety of immunization with one dose of RSV vaccine in IRD patients with active antirheumatic treatment compared to immunocompetent controls.

Conditions and MedDRA coding

Inflammatory rheumatic disease

VersionLevelCodeTermSystem organ class
23.1 PT 10018250 Giant cell arteritis 10047065
21.1 LLT 10056222 Systemic necrotising vasculitis 10047065
20.0 PT 10036030 Polyarthritis 100000004859
21.0 LLT 10037160 Psoriatic arthritis 10028395
23.1 PT 10039073 Rheumatoid arthritis 100000004859
20.0 LLT 10058338 Spondylarthritis 10028395
21.1 PT 10042945 Systemic lupus erythematosus 100000004859
23.1 LLT 10059177 Juvenile arthritis 10028395
21.0 PT 10036099 Polymyalgia rheumatica 100000004859

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. The subject has given their written consent to participate in the trial.
  2. Age ≥60 years.
  3. Having regular follow-up at rheumatology department in Lund, Malmö or Kristianstad
  4. Receiving immunomodulating treatment for at least 3 months (only for patients)

Exclusion criteria 6

  1. Immunodeficiency (not related to immunomodulating antirheumatic treatment)
  2. Changes of immunomodulating treatment four weeks before the vaccination
  3. Not willing to get vaccinated against RSV
  4. Prior vaccination against RSV
  5. Fever or ongoing infection
  6. Hypersensitivity to the active substances or to any of the excipients of both RSV vaccines (Abrysvo and Arexvy).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Antibody response, i.e. fold-change of RSVpreF-specific IgG antibody level from pre- to post-vaccination (3-6 weeks).

Secondary endpoints 2

  1. Functional RSVpreF-antigen specific T-cell response.
  2. Reported adverse events.

Investigational products

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

Test 2

Abrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent, recombinant)

PRD10762360 · Product

Active substance
Respiratory Syncytial Virus, Subgroup a, Stabilized Prefusion F Protein 847A
Substance synonyms
PF-06928316 (847A), RSV subgroup A stabilized prefusion F protein (847A)
Pharmaceutical form
SOLUTION 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
J07BX05 — -
Marketing authorisation
EU/1/23/1752/005
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Arexvy powder and suspension for suspension for injection Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)

PRD10447593 · Product

Active substance
Respiratory Syncytial Virus, Glycoprotein F, Recombinant, Stabilised in the Pre-Fusion Conformation, Adjuvanted with AS01E
Substance synonyms
GSKVx000000017064, RSVPreF3, adjuvanted with AS01E
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
J07BX05 — -
Marketing authorisation
EU/1/23/1740/002
MA holder
GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

32 Total trials 13 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Region Skane
Address
Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri
City
Malmo
Postcode
211 74
Country
Sweden

Scientific contact point

Organisation
Region Skane
Contact name
Per Nived

Public contact point

Organisation
Region Skane
Contact name
Per Nived

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Authorised, recruitment pending 180 2
Rest of world — 0 —

Investigational sites

Sweden

2 sites · Authorised, recruitment pending
Region Skane Kristianstad Central Hospital
Infectious diseases, J A Hedlunds Vag 5, Kristianstads Heliga Trefaldighet, Kristianstad
Region Skane Skanes Universitetssjukhus
Rheumatology, Entregatan 7, 222 42, Lund

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) FormularRSVREUMA250324 1
Protocol (for publication) Trial_protocol 2.0
Recruitment arrangements (for publication) forfarande-for-rekrytering-och-samtyckesprocess_ifyllt 1
Subject information and informed consent form (for publication) Information till forsoksperson 2.0
Subject information and informed consent form (for publication) Information till forsoksperson friska kontroller 1
Summary of Product Characteristics (SmPC) (for publication) abrysvo_smpc 1
Summary of Product Characteristics (SmPC) (for publication) arexvy_smpc 1
Synopsis of the protocol (for publication) Synopsis_svenska 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-04-18 Sweden Acceptable
2025-07-08
 2025-07-09

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