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

Purpose

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.

Condition	Intervention	Phase
HIV Infection Rheumatic Disease Cancer Transplant Pediatrics	Biological: Adjuvanted influenza A(H1N1) vaccines	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Cancer Flu HIV/AIDS

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Antibody responses (inhibition of hemagglutination) [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	1141
Study Start Date:	November 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High-risk patients ( 5 cohorts)	Biological: Adjuvanted influenza A(H1N1) vaccines Immunization (1-2 doses) Other Names: Pandemrix (GSK) Focetria (Novartis)
Active Comparator: Healthy controls	Biological: Adjuvanted influenza A(H1N1) vaccines Immunization (1-2 doses) Other Names: Pandemrix (GSK) Focetria (Novartis)

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.

Eligibility

Ages Eligible for Study:	6 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

medically recommended influenza A(H1N1) immunization
signed informed consent

Exclusion Criteria:

failure or refusal to provide sufficient blood for antibody determination

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022905

Locations

Switzerland
University Hospitals of Geneva
Geneva, Switzerland, 1211

Sponsors and Collaborators

University Hospital, Geneva

More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Prof. Claire-Anne Siegrist, University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT01022905 History of Changes
Other Study ID Numbers:	CER-09-234
Study First Received:	November 30, 2009
Last Updated:	February 26, 2010
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

HIV infection
transplant
rheumatic disease
cancer
children

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Influenza, Human
Rheumatic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 23, 2013