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

Phase 4

Completed

• Conditions: Rheumatic Disease; Transplant; Pediatrics; HIV Infection; Cancer
• Interventions: Biological: Adjuvanted influenza A(H1N1) vaccines

• Registration Number: NCT01022905
• Lead Sponsor: University Hospital, Geneva

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 Timeline

• Status Verified: 2009-02
• Study Start: 2009-11
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-26
• Last Update Posted: 2010-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1141

Inclusion Criteria

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

Exclusion Criteria

• failure or refusal to provide sufficient blood for antibody determination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-risk patients ( 5 cohorts)	Adjuvanted influenza A(H1N1) vaccines	-
Healthy controls	Adjuvanted influenza A(H1N1) vaccines	-

Primary Outcome Measures

Name	Time	Method
Antibody responses (inhibition of hemagglutination)	4-6 weeks after immunization

Secondary Outcome Measures

Name	Time	Method
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
Antibody responses (neutralization)	4-6 weeks after immunization
T cell responses	4-6 wks after immunization

Trial Locations

Locations (1)

University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland