Imiquimod and Influenza Vaccine for Immunocompromised Patients
NCT ID: NCT02960815
Last Updated: 2017-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2016-11-30
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Mutagrip
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.
Intanza
Aldara
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.
Mutagrip
Aldara
Interventions
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Intanza
Mutagrip
Aldara
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Lausanne Hospitals
OTHER
Responsible Party
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Oriol Manuel
PD Dr
Principal Investigators
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Oriol Manuel, MD
Role: PRINCIPAL_INVESTIGATOR
CHUV
Locations
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CHUV
Lausanne, , Switzerland
Countries
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References
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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.
Other Identifiers
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2016-01540
Identifier Type: -
Identifier Source: org_study_id