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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Goethe University.
Recruitment status was:  Recruiting
Information provided by:
Goethe University Identifier:
First received: November 19, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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 Intervention Phase
HIV-1 Infection
Other: serologic testing
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate potential adverse reactions of the H1N1 vaccine [ Time Frame: baseline, day 21, day 42 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: November 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: serologic testing
    Serologic testing will be performed baseline, day 21 and day 42
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.

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

Inclusion Criteria:

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

Exclusion Criteria:

  • not willing to participate
  Contacts and Locations
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Please refer to this study by its identifier: NCT01017172

Frankfurt, Germany, 60590
Sponsors and Collaborators
Goethe University
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
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Markus Bickel / MD, HIVCENTER, JW Goethe University Clinic Identifier: NCT01017172     History of Changes
Other Study ID Numbers: JWG11.2009 
Study First Received: November 19, 2009
Last Updated: November 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices processed this record on January 14, 2017