Clinical trial NCT02960815: Imiquimod and Influenza Vaccine for Immunocompromised Patients
Official title: Safety and Immunogenicity of Seasonal Influenza Vaccine With Topical Imiquimod in Immunocompromised Patients: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza Vaccine
Keywords: influenza vaccine
Transplantation
imiquimod
HIV infection
immunogenicity
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2016-11-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Response to the vaccine
timeFrame: 21 days after vaccination
Secondary outcomes:
measure: Seroprotection rates
timeFrame: Baseline, 21 and 180 days after vaccination
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: CHUV
name: Oriol Manuel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manuel O, Pascual M, Hoschler K, Giulieri S, Alves D, Ellefsen K, Bart PA, Venetz JP, Calandra T, Cavassini M. Humoral response to the influenza A H1N1/09 monovalent AS03-adjuvanted vaccine in immunocompromised patients. Clin Infect Dis. 2011 Jan 15;52(2):248-56. doi: 10.1093/cid/ciq104.
citation: Cordero E, Manuel O. Influenza vaccination in solid-organ transplant recipients. Curr Opin Organ Transplant. 2012 Dec;17(6):601-8. doi: 10.1097/MOT.0b013e3283592622.
citation: Manuel O, Humar A, Berutto C, Ely L, Giulieri S, Lien D, Meylan PR, Weinkauf J, Pascual M, Nador R, Aubert JD, Kumar D. Low-dose intradermal versus intramuscular trivalent inactivated seasonal influenza vaccine in lung transplant recipients. J Heart Lung Transplant. 2011 Jun;30(6):679-84. doi: 10.1016/j.healun.2011.01.705. Epub 2011 Mar 5.