Imiquimod and Influenza Vaccine for Immunocompromised Patients

Influenza Vaccine Clinical Trial

— IMIFLU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960815
• Other study ID #: 2016-01540
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2016
• Last updated: October 9, 2017
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza Vaccine
• Influenza, Human

Intervention

Biological:
• Intanza

• Mutagrip

Drug:
• Aldara

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. Review. — View 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 — View 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to the vaccine	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.	21 days after vaccination
Secondary	Seroprotection rates	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.	Baseline, 21 and 180 days after vaccination