NCT07925996Recruiting
Dermal Priming in Enhancing Vaccine Immunogenicity
Understanding the Impact of Local Dermal Priming in Enhancing Vaccine Immunogenicity in Patients Receiving B Cell Depleting Immunosuppression
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
Experimental medicine study in patients receiving B cell depletion therapy administering an immune challenge with seasonal influenza vaccination with/without concurrent administration of topical imiquimod (TLR7 agonist) aiming to determine proof of concept that local dermal immune priming alters physiological parameters following immunisation in this context.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 18 Oct 2026
- Start date
- 15 Dec 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT07925996
What you commit to
- Study type: Interventional
- Planned participants: 28
- From 15 Dec 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an autoimmune condition, such as ANCA associated vasculitis or IgG4 disease, who are receiving B cell depletion therapy such as rituximab. It tests a skin cream (imiquimod) given with a flu vaccine.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- An autoimmune condition (including but not limited to ANCA associated vasculitis and IgG4 disease), treated with B cell depletion therapy
- Earlier treatment
- Must be receiving B cell depletion therapy (for example rituximab). Last rituximab dose must be between 5 and 18 months before screening. No other immunosuppression in the last 3 months (oral prednisolone is allowed).
Main reasons for not taking part
- Systemic lupus erythematosus or Sjogren's syndrome
- Currently pregnant
- Oral prednisolone above 5mg daily
- Taking blood thinners or having a clotting disorder (low dose daily aspirin is allowed)
- Allergy to imiquimod or the influenza vaccine, or already had the current seasonal flu vaccine
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received immunosuppression in addition to rituximab in the last 3 months (oral prednisolone at any dose is permitted)
- Receiving oral prednisolone at a dose > 5mg daily
- Receiving anticoagulation (including warfarin, DOACs, clopidogrel, ticagrelor) for any indication or having any coagulation disorder. Low dose daily aspirin is permitted
- Prior vaccination with the current seasonal influenza vaccine
Other illness
- Has a diagnosis of systemic lupus erythematosus or Sjogren's syndrome
- Has a recent history (documented, confirmed or suspected) of a flu-like illness within a week of vaccination
- A known allergy or contraindications to imiquimod or influenza vaccine or excipients
- Have any condition that the investigator believes may interfere with successful completion of the study
Other
- Rituximab within less than 5 months or more than 18 months of screening
- Is currently pregnant
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | United Kingdom | Recruiting |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.