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

Conditions

Cancer, HIV Infection, Pediatrics, Rheumatic Disease, Transplant

Keywords

HIV infection, transplant, rheumatic disease, cancer, children

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.

Alcocer Bonifaz M, Bhavsar D, Siegrist CA, Didierlaurent A, Meyer B.

2026-01-07

10.1038/s41467-025-68137-x

Higher memory responses in HIV-infected and kidney transplanted patients than in healthy subjects following priming with the pandemic vaccine.

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).

2012-07-277 citations

10.1371/journal.pone.0040428

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.

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.

2011-03-2143 citations

10.3324/haematol.2011.040386

Antibody responses to natural influenza A/H1N1/09 disease or following immunization with adjuvanted vaccines, in immunocompetent and immunocompromised children.

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.

2011-03-1732 citations

10.1016/j.vaccine.2011.02.094

Interventions

BIOLOGICALAdjuvanted influenza A(H1N1) vaccines

Immunization (1-2 doses)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* failure or refusal to provide sufficient blood for antibody determination

Design outcomes

Primary

Measure	Time frame
Antibody responses (inhibition of hemagglutination)	4-6 weeks after immunization

Secondary

Measure	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

Countries

Switzerland

Outcome results

None listed