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Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients

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ClinicalTrials.gov Identifier: NCT01017172
Recruitment Status : Unknown
Verified November 2009 by Goethe University.
Recruitment status was:  Recruiting
First Posted : November 20, 2009
Last Update Posted : November 20, 2009
Sponsor:
Collaborator:
HIVCENTER
Information provided by:
Goethe University

Brief Summary:
The purpose of this study is to evaluate the immunogenicity and safety of an adjuvanted A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients after one and two injections.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Cancer Immunosuppression Other: serologic testing Phase 4

Detailed Description:
The efficacy of an adjuvanted A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients is unknown. Therefore we aim to investigate the immunoresponse as assessed by a anti-hemagglutinin assay before, 21 days after the first and 21 days after the second vaccination. The safety of the vaccination will be recorded by a standardized questionaire.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adults
Study Start Date : November 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot HIV/AIDS
U.S. FDA Resources


Intervention Details:
    Other: serologic testing
    Serologic testing will be performed baseline, day 21 and day 42


Primary Outcome Measures :
  1. To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients [ Time Frame: baseline, day 21, day 42 ]

Secondary Outcome Measures :
  1. To evaluate the effect of pre-existing anti-influenza immunity and recent history of seasonal influenza and H5N1 vaccination on seroresponses to the H1N1 influenza vaccine [ Time Frame: baseline ]
  2. To evaluate potential adverse reactions of the H1N1 vaccine [ Time Frame: baseline, day 21, day 42 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written informed consent
  • age >18
  • HIV-1 infection
  • cancer
  • immunosuppressive treatment

Exclusion Criteria:

  • not willing to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017172


Contacts
Contact: Markus Bickel, MD +49 69 6301 7478 markus.bickel@hivcenter.de
Contact: Christoph Stephan, MD +49 69 6301 7478 christoph.stephan@hivcenter.de

Locations
Germany
Hivcenter Recruiting
Frankfurt, Germany, 60590
Contact: Markus Bickel, MD    +49 69 6301 7478    markus.bickel@hivcenter.de   
Contact: Christoph Stephan, MD    +49 69 6301 7478    christoph.stephan@hivcenter.de   
Sponsors and Collaborators
Goethe University
HIVCENTER
Investigators
Study Director: Markus Bickel, MD JW Goethe University Clinic
Study Chair: Christoph Stephan, MD JW Goethe University Clinic
Principal Investigator: Hans R Brodt, MD JW Goethe University Clinic

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markus Bickel / MD, HIVCENTER, JW Goethe University Clinic
ClinicalTrials.gov Identifier: NCT01017172     History of Changes
Other Study ID Numbers: JWG11.2009
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: November 20, 2009
Last Verified: November 2009