Imiquimod and Influenza Vaccine for Immunocompromised Patients

University of Lausanne Hospitals70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Influenza Vaccine

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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