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 because the information has not been verified recently.
Verified November 2009 by Goethe University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
HIVCENTER
Information provided by:
Goethe University
ClinicalTrials.gov Identifier:
NCT01017172
First received: November 19, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 19, 2009
November 19, 2009
November 2009
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients
Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adults

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV-1 Infection
  • Cancer
  • Immunosuppression
Other: serologic testing
Serologic testing will be performed baseline, day 21 and day 42
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • not willing to participate
Both
18 Years and older
No
Contact: Markus Bickel, MD +49 69 6301 7478 markus.bickel@hivcenter.de
Contact: Christoph Stephan, MD +49 69 6301 7478 christoph.stephan@hivcenter.de
Germany
 
NCT01017172
JWG11.2009
No
Markus Bickel / MD, HIVCENTER, JW Goethe University Clinic
Goethe University
HIVCENTER
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
Goethe University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP