H1N1sw Vaccine in Adult Transplant Recipients

Study Overview
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Brief Summary
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The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.

Official Title
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A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers

Conditions
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Immunocompromised

Intervention / Treatment
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* Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment Patients able to visit the outpatient clinic with a life expectancy of at least one year Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection Exclusion Criteria: Individuals who received any vaccine within 30 days prior to study entry Individuals who received a H1N1 vaccination less than 6 months prior to the study Influenza diagnosed by a physician within 4 months prior to the study start Pregnant or lactating females History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transplanted adults<br>male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT | Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)<br>* 7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart<br>* Other names: Focetria(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents. |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration. |  | 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solid organ transplantation, bone marrow transplantation, adults, adults with solid organ transplantation, adults with bone marrow transplantation