A Phase 2 interventional study of Intanza and Mutagrip in Influenza Vaccine, sponsored by University of Lausanne Hospitals. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-10.
Sponsored by University of Lausanne Hospitals · Phase 2, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 70 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
For HIV-infected patients:
For kidney transplant recipients:
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.
Biological: Mutagrip
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.
Biological: Intanza · Drug: Aldara
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.
Biological: Mutagrip · Drug: Aldara
Response to the vaccine
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.
Time frame: 21 days after vaccination
Seroprotection rates
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.
Time frame: Baseline, 21 and 180 days after vaccination
Plan to share: No
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Lausanne Hospitals