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Clinical Trials

MainTitle

Imiquimod and Influenza Vaccine for Immunocompromised Patients (IMIFLU)

This study has been completed
Sponsor
University of Lausanne Hospitals


Information provided by (Responsible Party)
Oriol Manuel, University of Lausanne Hospitals

ClinicalTrials.gov Identifier
NCT02960815

First received: November 8, 2016
Last updated: October 9, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Influenza Vaccine

Biological : Intanza
Biological : Mutagrip
Drug : Aldara
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Seasonal Influenza Vaccine With Topical Imiquimod in Immunocompromised Patients: A Randomized Controlled Pilot Trial

Further study details as provided by Oriol Manuel, University of Lausanne Hospitals:

Primary Outcome Measures

  • 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.
Secondary Outcome Measures:
  • 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.

Enrollment: 70
Study Start Date: November 2016
Study Completion Date: June 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.
Biological: Mutagrip
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.
Biological: Intanza
Drug: Aldara
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.
Biological: Mutagrip
Drug: Aldara
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02960815

Locations

Switzerland
CHUV
Lausanne, Switzerland, 1011

Sponsors and Collaborators

University of Lausanne Hospitals

Investigators

Principal Investigator: Oriol Manuel, MD CHUV
More Information

More Information


Responsible Party: Oriol Manuel, PD Dr, University of Lausanne Hospitals  
ClinicalTrials.gov Identifier: NCT02960815   History of Changes  
Other Study ID Numbers: 2016-01540  
Study First Received: November 8, 2016  
Last Updated: October 9, 2017  

Keywords provided by Oriol Manuel, University of Lausanne Hospitals:

influenza vaccine
Transplantation
imiquimod
HIV infection
immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Vaccines
Imiquimod

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.