Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02960815
Other study ID # 2016-01540
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03285997 - A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age Phase 3
Recruiting NCT05996549 - Cost-effectiveness of the Influenza Vaccination Phase 4
Completed NCT04546854 - Influenza 2020/2021 N/A
Completed NCT05157425 - Effect of a Multi-strain Probiotic Formulation on Immune Response to Influenza Vaccination N/A
Completed NCT01687517 - Efficacy and Safety of Influenza Vaccine During Sarcoidosis Phase 3
Completed NCT01180699 - Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients N/A
Completed NCT00760175 - Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients N/A
Completed NCT00542776 - Impact of Immunosuppression in IBD Patients on Response to Influenza Vaccine N/A
Completed NCT06304038 - Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome
Recruiting NCT04086628 - Influenza Vaccine in Children With Asthma
Completed NCT00828555 - Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting N/A
Completed NCT04230343 - Limits of the Social Benefit Motive Among High-risk Patients: a Field Experiment on Influenza Vaccination Behaviour N/A
Recruiting NCT03399357 - Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population - the DYNAMIC Trial N/A
Completed NCT02153671 - Immunogenicity of H5N1 Vaccine Following H5N2 Phase 2
Completed NCT00461981 - A Phase 2 Study to Evaluate Immune Responses of FluMist® Phase 2
Recruiting NCT05070494 - Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients Phase 4
Completed NCT04785794 - Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old Phase 1
Completed NCT05163847 - Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults Phase 1
Not yet recruiting NCT04355806 - Impact of Inactivated Trivalent Influenza Vaccine on NSCLC Patients Receiving PD-1 / PD-L1 Inhibitors
Completed NCT01368796 - Comparison of 4 Influenza Vaccines in Seniors Phase 4