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

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT01022905

First received: November 30, 2009

Last updated: February 26, 2010

Last verified: February 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	November 30, 2009
Last Updated Date	February 26, 2010
Start Date ^ICMJE	November 2009
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 30, 2009)	Antibody responses (inhibition of hemagglutination) [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01022905 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 30, 2009)	Antibody responses (neutralization) [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: Yes ] T cell responses [ Time Frame: 4-6 wks after immunization ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: November 30, 2009)	Antibody responses (neutralization) [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: No ] Solicited adverse events [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: Yes ] T cell responses [ Time Frame: 4-6 wks after immunization ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients
Official Title ^ICMJE	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	HIV Infection Rheumatic Disease Cancer Transplant Pediatrics
Intervention ^ICMJE	Biological: Adjuvanted influenza A(H1N1) vaccines Immunization (1-2 doses) Other Names: Pandemrix (GSK) Focetria (Novartis)
Study Arm (s)	Experimental: High-risk patients ( 5 cohorts) Intervention: Biological: Adjuvanted influenza A(H1N1) vaccines Active Comparator: Healthy controls Intervention: Biological: Adjuvanted influenza A(H1N1) vaccines
Publications *	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. Epub 2012 Jul 27. 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. Epub 2011 Mar 21. Meier S, Bel M, L'huillier A, Crisinel PA, Combescure C, Kaiser L, Grillet S, Pósfay-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. Epub 2011 Mar 17. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1141
Completion Date	February 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: medically recommended influenza A(H1N1) immunization signed informed consent Exclusion Criteria: failure or refusal to provide sufficient blood for antibody determination
Gender	Both
Ages	6 Months and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01022905
Other Study ID Numbers ^ICMJE	CER-09-234
Has Data Monitoring Committee	No
Responsible Party	Prof. Claire-Anne Siegrist, University Hospital, Geneva
Study Sponsor ^ICMJE	University Hospital, Geneva
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Geneva
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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