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RecruitingNCT07925996Updated Nov 9, 2026

Dermal Priming in Enhancing Vaccine Immunogenicity

An interventional study of Imiquimod (topical use) and Aqueous cream in ANCA Associated Vasculitis (AAV), IgG4 Related Disease and Glomerular Diseases, sponsored by Cambridge University Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2025, registered Oct 2026).
  • Started Dec 2025; still recruiting 10 months later.
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • ANCA Associated Vasculitis (AAV)
  • IgG4 Related Disease
  • Glomerular Diseases
03

In context

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.

This study's planned enrollment of 28 is below the median of 34 across 116 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.

Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 171 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with an 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 for participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Has received 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 to imiquimod or influenza vaccine or
  • Prior vaccination with the current seasonal influenza vaccine
  • Have any condition that the investigator believes may interfere with successful completion of the study
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Group 1: topical imiquimod (5% Aldara) + influenza vaccine

    Topical imiquimod (5% Aldara) + influenza vaccine

    Drug: Imiquimod (topical use)

  • Placebo comparator
    Group 2: Topical placebo + influenza vaccine

    Topical placebo + influenza vaccine

    Drug: Aqueous cream

  • Sham comparator
    Group 3: topical imiquimod (5% Aldara) + saline (sham) vaccine

    Drug: Imiquimod (topical use)

Interventions

  • Topical application at site of influenza vaccine administration

    Also known as: Aldara 5%

  • DrugAqueous cream

    Topical aqueous cream

06

What researchers measure

Primary outcomes

  1. Change in influenza-specific antibody neutralising capacity

    Comparison between patients that received imiquimod and placebo

    Time frame: Comparison between baseline and day 28

Secondary outcomes

  1. Change in influenza-specific antibody neutralising capacity

    Comparison between patients that received imiquimod and placebo

    Time frame: day 90

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07925996
Responsible party
Dr. Rona Smith (Associate Professor of Nephrology, Cambridge University Hospitals NHS Foundation Trust) — Principal investigator
First posted
Nov 9, 2026
Start date
Dec 15, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Rona Smith, MD
Contact
rona.smith@nhs.net
00441223217259

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Imiquimod

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