Imiquimod and Influenza Vaccine for Immunocompromised Patients (IMIFLU)
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|ClinicalTrials.gov Identifier: NCT02960815|
Recruitment Status : Completed
First Posted : November 10, 2016
Last Update Posted : October 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Influenza Vaccine||Biological: Intanza Biological: Mutagrip Drug: Aldara||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Immunogenicity of Seasonal Influenza Vaccine With Topical Imiquimod in Immunocompromised Patients: A Randomized Controlled Pilot Trial|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
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.
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.
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.
- Response to the vaccine [ Time Frame: 21 days after vaccination ]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.
- Seroprotection rates [ Time Frame: Baseline, 21 and 180 days after vaccination ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960815
|Lausanne, Switzerland, 1011|
|Principal Investigator:||Oriol Manuel, MD||CHUV|