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Influenza VaccinePhase 2IMIFLUNCT02960815

Imiquimod and Influenza Vaccine for Immunocompromised Patients

A Phase 2 study testing Intanza, Mutagrip and Aldara in people with Influenza Vaccine, run by University of Lausanne Hospitals at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza Vaccine
What is being tested?
Intanza, Mutagrip and Aldara
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSwitzerland
Study dates
Nov 2016to Jun 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

Switzerland1 site

  • CHUV

    Lausanne, 1011

Other trials in Switzerland

About this study

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

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.

Being tested
Intanza, Mutagrip, Aldara
Keywords
influenza vaccine, Transplantation, imiquimod, HIV infection, immunogenicity
Medical subject headings
Influenza, Human, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IntanzaBiological

  • MutagripBiological

  • AldaraDrug

Study groups in NCT02960815
Study groupRoleWhat they receive
Intramuscular vaccineActive comparatorThe 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.
Receives: Biological: Mutagrip
Imiquimod and intradermal vaccineExperimentalIn 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.
Receives: Biological: Intanza; Drug: Aldara
Imiquimod and intramuscular vaccineExperimentalIn 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.
Receives: Biological: Mutagrip; Drug: Aldara

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 21 days after vaccination

Secondary outcomes (1)

  1. 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.

    Measured: Baseline, 21 and 180 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02960815
Sponsor's protocol ID
2016-01540
Other IDs
2016
Acronym
IMIFLU
Status last verified
Oct 2017
First submitted
8 Nov 2016
Last updated
10 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21288852

  • 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.

    PubMed 23042206

  • 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.

    PubMed 21377898

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intanza, Mutagrip and Aldara in people with Influenza Vaccine, run by University of Lausanne Hospitals at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to the vaccine (time frame: 21 days after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02960815, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.

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