Imiquimod and Influenza Vaccine for Immunocompromised Patients
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
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.