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OpenTrials
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NCT Number: NCT00783380

Influenza Vaccination in Immunocompromized Patients

Evaluation of the immunogenicity and reactogenicity of two different formulations of commercially avail-able influenza vaccines in 4 different groups of immunocompromized outpatients (HIV positive patients, patients suffering from rheumatologic diseases and receiving treatment with immunosuppressive drugs and patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis). The aim of the study was to investigate if the newest formulation of influenza vaccines (virosomal vaccines) offer a benefit in immunocompromized patients in comparison to an older subunit formulation.

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Key information

Conditions

Immunosuppression Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Influenza, Human Lentivirus Infections Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Infectious Diseases, Bern University Hospital, Bern, Switzerland

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About this study

The infection with influenza is associated with higher morbidity and mortality in risk groups including immunocompromized patients. The virosomal influenza vaccines have been associated with improved immunogenicity in former trials. No direct comparison with older formulations has been conducted so far.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult outpatients treated at the Inselspital Bern for:
  • HIV infection
  • rheumatologic diseases and receiving immunosuppressive drugs
  • kidney transplant recipients
  • undergoing hemodialysis or continuous ambulatory peritoneal dialysis
  • written informed consent

Exclusion criteria

  • Allergy to egg proteins
  • Former adverse reactions to prior vaccination
  • Febrile conditions at the time of study inclusion

Treatment and study plan

Virosomal influenza vaccine

Biological

Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients

Subunit influenza vaccine

Biological

Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients

Primary outcomes

  1. Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)

    Time frame: >60 Wochen

Secondary outcomes

  1. Reactogenicity in rheumatologic patients by disease specific scores

    Time frame: Six weeks after vaccination

  2. Immediate side effects at time of application of vaccination

    Time frame: Minutes after vaccination

  3. Side effects after vaccination

    Time frame: First week after vaccination

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Abbott
  • Boehringer Ingelheim
  • Merck Sharp & Dohme LLC
  • Solvay Pharmaceuticals

Registry information

Official study title

Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Oct 31, 2008
Registry last updated
Nov 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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