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

Primary Purpose

HIV Infection, Rheumatic Disease, Cancer

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Adjuvanted influenza A(H1N1) vaccines
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV infection, transplant, rheumatic disease, cancer, children

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • medically recommended influenza A(H1N1) immunization
  • signed informed consent

Exclusion Criteria:

  • failure or refusal to provide sufficient blood for antibody determination

Sites / Locations

  • University Hospitals of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-risk patients ( 5 cohorts)

Healthy controls

Arm Description

Outcomes

Primary Outcome Measures

Antibody responses (inhibition of hemagglutination)

Secondary Outcome Measures

Antibody responses (neutralization)
Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases)
T cell responses

Full Information

First Posted
November 30, 2009
Last Updated
February 26, 2010
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT01022905
Brief Title
Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Rheumatic Disease, Cancer, Transplant, Pediatrics
Keywords
HIV infection, transplant, rheumatic disease, cancer, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-risk patients ( 5 cohorts)
Arm Type
Experimental
Arm Title
Healthy controls
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Adjuvanted influenza A(H1N1) vaccines
Other Intervention Name(s)
Pandemrix (GSK), Focetria (Novartis)
Intervention Description
Immunization (1-2 doses)
Primary Outcome Measure Information:
Title
Antibody responses (inhibition of hemagglutination)
Time Frame
4-6 weeks after immunization
Secondary Outcome Measure Information:
Title
Antibody responses (neutralization)
Time Frame
4-6 weeks after immunization
Title
Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases)
Time Frame
4-6 weeks after immunization
Title
T cell responses
Time Frame
4-6 wks after immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: medically recommended influenza A(H1N1) immunization signed informed consent Exclusion Criteria: failure or refusal to provide sufficient blood for antibody determination
Facility Information:
Facility Name
University Hospitals of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22848378
Citation
Siegrist CA, van Delden C, Bel M, Combescure C, Delhumeau C, Cavassini M, Clerc O, Meier S, Hadaya K, Soccal PM, Yerly S, Kaiser L, Hirschel B, Calmy A; H1N1 Study Group; Swiss HIV Cohort Study (SHCS). Higher memory responses in HIV-infected and kidney transplanted patients than in healthy subjects following priming with the pandemic vaccine. PLoS One. 2012;7(7):e40428. doi: 10.1371/journal.pone.0040428. Epub 2012 Jul 27.
Results Reference
derived
PubMed Identifier
22228003
Citation
Schappi MG, Meier S, Bel M, Siegrist CA, Posfay-Barbe KM; H1N1 Study Group. Protective antibody responses to influenza A/H1N1/09 vaccination in children with celiac disease. J Pediatr Gastroenterol Nutr. 2012 Jun;54(6):817-9. doi: 10.1097/MPG.0b013e318248e7be.
Results Reference
derived
PubMed Identifier
21422117
Citation
Mohty B, Bel M, Vukicevic M, Nagy M, Levrat E, Meier S, Grillet S, Combescure C, Kaiser L, Chalandon Y, Passweg J, Siegrist CA, Roosnek E; Blood and Marrow Transplant Program; Geneva University Hospitals H1N1 study group. Graft-versus-host disease is the major determinant of humoral responses to the AS03-adjuvanted influenza A/09/H1N1 vaccine in allogeneic hematopoietic stem cell transplant recipients. Haematologica. 2011 Jun;96(6):896-904. doi: 10.3324/haematol.2011.040386. Epub 2011 Mar 21.
Results Reference
derived
PubMed Identifier
21419775
Citation
Meier S, Bel M, L'huillier A, Crisinel PA, Combescure C, Kaiser L, Grillet S, Posfay-Barbe K, Siegrist CA; H1N1 Epidemiology Study Group of Geneva. Antibody responses to natural influenza A/H1N1/09 disease or following immunization with adjuvanted vaccines, in immunocompetent and immunocompromised children. Vaccine. 2011 Apr 27;29(19):3548-57. doi: 10.1016/j.vaccine.2011.02.094. Epub 2011 Mar 17.
Results Reference
derived
PubMed Identifier
21384334
Citation
Gabay C, Bel M, Combescure C, Ribi C, Meier S, Posfay-Barbe K, Grillet S, Seebach JD, Kaiser L, Wunderli W, Guerne PA, Siegrist CA; H1N1 Study Group. Impact of synthetic and biologic disease-modifying antirheumatic drugs on antibody responses to the AS03-adjuvanted pandemic influenza vaccine: a prospective, open-label, parallel-cohort, single-center study. Arthritis Rheum. 2011 Jun;63(6):1486-96. doi: 10.1002/art.30325.
Results Reference
derived

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

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