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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017172
First Posted: November 20, 2009
Last Update Posted: November 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
HIVCENTER
Information provided by:
Goethe University
  Purpose
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 Cancer Immunosuppression Other: serologic testing Phase 4

Study Type: Interventional
Study Design: 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

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 ]

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 ]
  • To evaluate potential adverse reactions of the H1N1 vaccine [ Time Frame: baseline, day 21, day 42 ]

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: November 19, 2009
First Posted: November 20, 2009
Last Update Posted: November 20, 2009
Last Verified: November 2009