NCT07925996 Dermal Priming in Enhancing Vaccine Immunogenicity
| NCT ID | NCT07925996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust |
| Condition | ANCA Associated Vasculitis (AAV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2025-12-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07925996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ANCA Associated Vasculitis (AAV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07925996 currently recruiting?
Yes, NCT07925996 is actively recruiting participants. Contact the research team at rona.smith@nhs.net for enrollment information.
Where is the NCT07925996 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom.
Who is sponsoring the NCT07925996 clinical trial?
NCT07925996 is sponsored by Cambridge University Hospitals NHS Foundation Trust. The trial plans to enroll 28 participants.