Imiquimod and Influenza Vaccine for Immunocompromised Patients (IMIFLU)
October 9, 2017 updated by: Oriol Manuel, University of Lausanne Hospitals
Safety and Immunogenicity of Seasonal Influenza Vaccine With Topical Imiquimod in Immunocompromised Patients: A Randomized Controlled Pilot Trial
In this open label, single centre, pilot randomized controlled clinical trial the investigators aim to compare the immunogenicity and safety of a new influenza vaccination strategy consisting in the topical administration of imiquimod at the injection site before vaccination vs. a standard intramuscular vaccine injection in SOT recipients and HIV-infected individuals.
The investigators planned to enroll 70 outpatients patients (50% solid-organ transplant recipients and 50% HIV-infected patients) regularly followed at the Transplantation center and the Infectious disease outpatients' clinics of the Lausanne University Hospital.
Study participants will be randomized in a 1:1:1 ratio to receive the standard intramuscular vaccine (control group) or a topical application of an imiquimod containing cream followed by intramuscular (imiquimod-IM) or intradermal (imiquimod-ID) vaccine injection.
After vaccination participants will be followed for a period of 180 days.
Blood samples will be drawn at baseline and at day 21 and 180 for assessment of immunogenicity.
Safety outcomes will be assessed immediately after vaccine administration, and at day 7 (phone call), 21 and 180.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lausanne, Switzerland, 1011
- CHUV
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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:
- Provision of written, informed consent
- Age > 18 years
- HIV infection or at least 3 months after kidney transplantation
- Stable outpatients
- Able and willing to comply with the study protocol
Exclusion Criteria:
- Documented egg and/or imiquimod allergy
- Previous life-threatening reaction to seasonal influenza vaccine (i.e. Guillain-Barré Syndrome)
- Previous severe reaction to imiquimod cream
- Pregnancy or breast-feeding
- Patients with autoimmune diseases
For HIV-infected patients:
- Current active opportunistic infection
For kidney transplant recipients:
- Ongoing therapy for rejection (including steroid pulse or prednisone > 2 mg/kg/day over more than 14 days)
- Ongoing therapy with IVIG and eculizumab or current and past (<6months) therapy with rituximab
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Intramuscular vaccine
The control intervention consists in the administration of the standard intramuscular influenza vaccine (Mutagrip®), containing 15 μg of each of the three viral strains without imiquimod.
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EXPERIMENTAL: Imiquimod and intradermal vaccine
In the imiquimod and intradermal vaccine arm, intervention consists in the topical application of a single bag of Aldara™ creme 5%, containing 12.5 mg of imiquimod, on a 16 cm2 square delimitated area on the non-dominant arm at the time of influenza vaccination.
An intradermal influenza vaccine preparations containing 15 μg of each of the three viral strains (Intanza®) will be administrated in the centre of the marked area after the imiquimod cream is fully absorbed.
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EXPERIMENTAL: Imiquimod and intramuscular vaccine
In the imiquimod and intramuscular vaccine arm, intervention consists in the topical application of a single bag of Aldara™ creme 5%, containing 12.5 mg of imiquimod, on a 16 cm2 square delimitated area on the non-dominant arm at the time of influenza vaccination.
An intramuscular influenza vaccine preparations containing 15 μg of each of the three viral strains (Mutagrip®) will be administrated in the centre of the marked area after the imiquimod cream is fully absorbed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Response to the vaccine
Time Frame: 21 days after vaccination
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Vaccine response rate (=seroconversion rate) at day 21 is the proportion of participants exhibiting a fourfold or greater increase of anti haemagglutinin (anti-HA) antibodies from baseline, measured by haemagglutinin inhibition (HI) assay 21 days after vaccination, for at least one viral strain.
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21 days after vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Seroprotection rates
Time Frame: Baseline, 21 and 180 days after vaccination
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Seroprotection rates for each vaccine strain at baseline, and 21 and 180 days after vaccination.
Seroprotection rate is defined as the proportion of patients exhibiting an anti-HA antibody titer of 1:32 or greater.
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Baseline, 21 and 180 days after vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oriol Manuel, MD, CHUV
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Manuel O, Pascual M, Hoschler K, Giulieri S, Alves D, Ellefsen K, Bart PA, Venetz JP, Calandra T, Cavassini M. Humoral response to the influenza A H1N1/09 monovalent AS03-adjuvanted vaccine in immunocompromised patients. Clin Infect Dis. 2011 Jan 15;52(2):248-56. doi: 10.1093/cid/ciq104.
- Cordero E, Manuel O. Influenza vaccination in solid-organ transplant recipients. Curr Opin Organ Transplant. 2012 Dec;17(6):601-8. doi: 10.1097/MOT.0b013e3283592622.
- Manuel O, Humar A, Berutto C, Ely L, Giulieri S, Lien D, Meylan PR, Weinkauf J, Pascual M, Nador R, Aubert JD, Kumar D. Low-dose intradermal versus intramuscular trivalent inactivated seasonal influenza vaccine in lung transplant recipients. J Heart Lung Transplant. 2011 Jun;30(6):679-84. doi: 10.1016/j.healun.2011.01.705. Epub 2011 Mar 5.
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
November 1, 2016
Primary Completion (ACTUAL)
June 1, 2017
Study Completion (ACTUAL)
June 1, 2017
Study Registration Dates
First Submitted
November 8, 2016
First Submitted That Met QC Criteria
November 9, 2016
First Posted (ESTIMATE)
November 10, 2016
Study Record Updates
Last Update Posted (ACTUAL)
October 10, 2017
Last Update Submitted That Met QC Criteria
October 9, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-01540
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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