NCT02960815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

November 8, 2016

Last Update Submit

October 9, 2017

Conditions

Influenza Vaccine

Keywords

influenza vaccineTransplantationimiquimodHIV infectionimmunogenicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Seroprotection rates

    Baseline, 21 and 180 days after vaccination

Study Arms (3)

Intramuscular vaccine

ACTIVE COMPARATOR

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

Imiquimod and intradermal vaccine

EXPERIMENTAL

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: IntanzaDrug: Aldara

Imiquimod and intramuscular vaccine

EXPERIMENTAL

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: MutagripDrug: Aldara

Interventions

IntanzaBIOLOGICAL
Imiquimod and intradermal vaccine
MutagripBIOLOGICAL
Imiquimod and intramuscular vaccineIntramuscular vaccine
AldaraDRUG
Imiquimod and intradermal vaccineImiquimod and intramuscular vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV

Lausanne, 1011, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 21288852RESULT

  • 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.

    PMID: 23042206RESULT

  • 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.

    PMID: 21377898RESULT

MeSH Terms

Conditions

Influenza, HumanHIV Infections

Interventions

mutagripImiquimod

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Oriol Manuel, MD

    CHUV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 10, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 10, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)