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Completed

NCT Number: NCT02960815

Imiquimod and Influenza Vaccine for Immunocompromised Patients

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.

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Key information

Conditions

Influenza Vaccine Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Influenza, Human Lentivirus Infections Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHUV

Lausanne, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intanza

Biological

Mutagrip

Biological

Aldara

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

Safety and Immunogenicity of Seasonal Influenza Vaccine With Topical Imiquimod in Immunocompromised Patients: A Randomized Controlled Pilot Trial

Acronym: IMIFLU

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 10, 2016
Registry last updated
Oct 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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