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

NCT01022905 | Completed Phase 4

• 1 other identifier: CER-09-234
• Study Type: interventional
• Target: 1,141
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Rheumatic Disease; Cancer; Transplant; Pediatrics

Keywords

HIV infection; transplant; rheumatic disease; cancer; children

Outcome Measures

Primary Outcomes (1)

• Antibody responses (inhibition of hemagglutination)

  4-6 weeks after immunization

Secondary Outcomes (3)

• 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

Study Arms (2)

High-risk patients ( 5 cohorts)

EXPERIMENTAL

Biological: Adjuvanted influenza A(H1N1) vaccines

Healthy controls

ACTIVE COMPARATOR

Biological: Adjuvanted influenza A(H1N1) vaccines

Interventions

Adjuvanted influenza A(H1N1) vaccines BIOLOGICAL

Immunization (1-2 doses)

Also known as: Pandemrix (GSK), Focetria (Novartis)

Healthy controls; High-risk patients ( 5 cohorts)

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• failure or refusal to provide sufficient blood for antibody determination

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 22848378 DERIVED

• 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.

  PMID: 22228003 DERIVED

• 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.

  PMID: 21422117 DERIVED

• 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.

  PMID: 21419775 DERIVED

• 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.

  PMID: 21384334 DERIVED

MeSH Terms

Conditions

HIV Infections; Rheumatic Diseases; Neoplasms

Interventions

Vaccines; pandemrix; halofantrine; focetria; lactitol

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 1, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 1, 2010

Record last verified: 2009-02

Locations

CH (1)