Clinical trial NCT01022905: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Rheumatic Disease
Cancer
Transplant
Pediatrics
Keywords: HIV infection
transplant
rheumatic disease
cancer
children
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 1141
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Antibody responses (inhibition of hemagglutination)
timeFrame: 4-6 weeks after immunization
Secondary outcomes:
measure: Antibody responses (neutralization)
timeFrame: 4-6 weeks after immunization
measure: Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases)
timeFrame: 4-6 weeks after immunization
measure: T cell responses
timeFrame: 4-6 wks after immunization
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
References:
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.
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.
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.
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.
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.