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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 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
  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
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:

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Institute Homepage  This link exits the ClinicalTrials.gov site
Institute Homepage  This link exits the ClinicalTrials.gov site

No publications provided by Goethe University

Additional 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
Study First Received: November 19, 2009
Last Updated: November 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Influenza, Human
HIV Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
 Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013