Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients

Study Overview
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Brief Summary
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The objective of this study is to assess vaccine responses to novel adjuvanted influenza A(H1N1) vaccines in patients at high risks of influenza A(H1N1) complications.

Detailed Description
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This prospective, open-label, parallel-cohorts study will include up to 1250 patients and 250 controls to whom influenza A(H1N1) immunization was recommended. Six cohort have been established, enrolling patients with HIV infection, rheumatic diseases, organ transplant, cancer, pediatric patients and healthy controls. Subjects will be assessed for specific antibody responses (all), T cell responses (subset) and solicited vaccine adverse events. Vaccine safety evaluation will include the influence of immunization on underlying diseases (HIV infected patients, patients with auto-immune diseases) or graft function (transplant patients) - as appropriate.

Official Title
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Prospective Cohort Study of the Influence of Age, Underlying Disease and Immunosuppression on Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients.

Conditions
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HIV Infection, Rheumatic Disease, Cancer, Transplant, Pediatrics

Intervention / Treatment
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* Biological: Adjuvanted influenza A(H1N1) vaccines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medically recommended influenza A(H1N1) immunization signed informed consent Exclusion Criteria: failure or refusal to provide sufficient blood for antibody determination

Ages Eligible for Study
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Minimum Age: 6 Months

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: High-risk patients ( 5 cohorts)<br> | Biological: Adjuvanted influenza A(H1N1) vaccines<br>* Immunization (1-2 doses)<br>* Other names: Focetria (Novartis);|
| Active Comparator: Healthy controls<br> | Biological: Adjuvanted influenza A(H1N1) vaccines<br>* Immunization (1-2 doses)<br>* Other names: Focetria (Novartis);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody responses (inhibition of hemagglutination) |  | 4-6 weeks after immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody responses (neutralization) |  | 4-6 weeks after immunization | 
| Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases) |  | 4-6 weeks after immunization | 
| T cell responses |  | 4-6 wks after immunization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infection, transplant, rheumatic disease, cancer, children