Dermal priming to boost flu vaccine response in people on B cell depletion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates whether local dermal immune priming using imiquimod cream, given with a seasonal influenza vaccine, can modify immune responses in patients already treated with B cell depletion therapy. The approach compares vaccination with and without concurrent topical imiquimod to see if the skin-directed boost enhances immunogenicity. Enrollment targets adults with autoimmune conditions such as ANCA-associated vasculitis or IgG4-related disease who are on rituximab or similar therapy. Exclusion criteria include recent immunosuppression beyond rituximab, certain autoimmune diseases, pregnancy, recent flu illness, and coagulation concerns. The study is led by Cambridge University Hospitals NHS Foundation Trust with collaborators from the University of Cambridge and is conducted at the Cambridge site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with an autoimmune condition (including but not limited to ANCA associated vasculitis, IgG4 disease) and receiving B cell depletion therapy (eg, rituximab).
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Has received immunosuppression in addition to rituximab in the last 3 months (oral prednisolone at any dose is permitted)
* Rituximab within less than 5 months or more than 18 months of screening
* Receiving oral prednisolone at a dose \> 5mg daily
* Has a diagnosis of systemic lupus erythematosus or Sjogren's syndrome
* Is currently pregnant
* Has a recent history (documented, confirmed or suspected) of a flu-like illness within a week of vaccination
* Receiving anticoagulation (including warfarin, DOACs, clopidogrel, ticagrelor) for any indication or having any coagulation disorder. Low dose daily aspirin is permitted
* A known allergy or contraindications to imiquimod or influenza vaccine or excipients
* Prior vaccination with the current seasonal influenza vaccine
* Have any condition that the investigator believes may interfere with successful completion of the study

Where it's running

• Cambridge University Hospitals NHS Foundation Trust
  Cambridge, United Kingdom Recruiting

Study contacts

• Study coordinator: Rona Smith, MD
• Email: rona.smith@nhs.net
• Phone: 00441223217259

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FT839 therapy for autoimmune diseases

  This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.

  Recruiting Phase 1/2 Fate Therapeutics · Fullerton, California · NCT07800871

• Obinutuzumab beta with low-dose steroids in new-onset ANCA-associated glomerulonephritis

  This study tests whether adding Obinutuzumab beta to a rapid-tapering glucocorticoid plan can help people with new-onset ANCA-associated glomerulonephritis see if they achieve remission.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing · NCT07746180

• FAPI‑74 PET/CT versus FDG PET/CT for inflammation in FUO, IgG4‑RD, and axial spondyloarthritis

  This project will test whether [18F]-AlF-FAPI-74 PET/CT finds inflammation more accurately than standard [18F]-FDG PET/CT in people with fever of unknown origin, IgG4‑related disease, or axial spondyloarthritis.

  Recruiting Phase 2/3 Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07535554

• MTS109 treatment for refractory autoimmune diseases

  This trial tests whether MTS109 (an mRNA-LNP given by subcutaneous injection) is safe and tolerable in adults with moderate to severe autoimmune diseases that have not responded to standard treatments.

  Recruiting Early Phase 1 Shanghai Changzheng Hospital · Shanghai, Shanghai Municipality · NCT07526350

• Dual-target CAR T therapy (CD19 and BCMA) for relapsed or treatment-resistant autoimmune diseases

  This will try a single infusion of off-the-shelf (allogeneic) CAR T-cells that target CD19 and BCMA in adults whose autoimmune disease has relapsed or not responded to other treatments.

  Recruiting Phase 1 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07315087

• Total-body PET scanning to find disease activity and cardiovascular risk in ANCA-associated vasculitis

  We will test whether whole-body PET scans with FDG, DOTATATE, and FAPI can detect active inflammation and identify people with active ANCA-associated vasculitis who are at higher long-term cardiovascular risk.

  Recruiting University of Edinburgh · Edinburgh · NCT07258524

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.