Dermal Priming in Enhancing Vaccine Immunogenicity

November 5, 2026 updated by: Dr. Rona Smith, Cambridge University Hospitals NHS Foundation Trust

Understanding the Impact of Local Dermal Priming in Enhancing Vaccine Immunogenicity in Patients Receiving B Cell Depleting Immunosuppression

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: topical imiquimod (5% Aldara) + influenza vaccine

Topical imiquimod (5% Aldara) + influenza vaccine
Drug: Imiquimod (topical use)

Topical application at site of influenza vaccine administration

Other Names:
  • Aldara 5%
Placebo Comparator: Group 2: Topical placebo + influenza vaccine

Topical placebo + influenza vaccine
Drug: Aqueous cream

Topical aqueous cream
Sham Comparator: Group 3: topical imiquimod (5% Aldara) + saline (sham) vaccine
Drug: Imiquimod (topical use)

Topical application at site of influenza vaccine administration

Other Names:
  • Aldara 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in influenza-specific antibody neutralising capacity
Time Frame: Comparison between baseline and day 28

Comparison between patients that received imiquimod and placebo
Comparison between baseline and day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in influenza-specific antibody neutralising capacity
Time Frame: day 90

Comparison between patients that received imiquimod and placebo
day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

University of Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

October 18, 2026

First Submitted That Met QC Criteria

November 5, 2026

First Posted (Actual)

November 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A097470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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