Imiquimod and Influenza Vaccine for Immunocompromised Patients (IMIFLU)

Lausanne University Hospital (CHUV)

Status and phase: Completed; Phase 2

Conditions: Influenza Vaccine

Treatments: Biological: Intanza; Biological: Mutagrip; Drug: Aldara

Study type: Interventional

Funder types: Other

Identifiers

NCT02960815

2016-01540

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Intramuscular vaccine

Active Comparator group

Description:

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.

Treatment:

Biological: Mutagrip

Imiquimod and intradermal vaccine

Experimental group

Description:

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.

Treatment:

Drug: Aldara

Biological: Intanza

Imiquimod and intramuscular vaccine

Experimental group

Description:

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.

Treatment:

Drug: Aldara

Biological: Mutagrip