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Imiquimod and Influenza Vaccine for Immunocompromised Patients (IMIFLU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02960815
Recruitment Status : Completed
First Posted : November 10, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Oriol Manuel, University of Lausanne Hospitals

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza Vaccine Biological: Intanza Biological: Mutagrip Drug: Aldara Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
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
Study Start Date : November 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

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


Locations
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Switzerland
CHUV
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
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Principal Investigator: Oriol Manuel, MD CHUV
Publications of Results:
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Responsible Party: Oriol Manuel, PD Dr, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02960815    
Other Study ID Numbers: 2016-01540
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Oriol Manuel, University of Lausanne Hospitals:
influenza vaccine
Transplantation
imiquimod
HIV infection
immunogenicity
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers