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

This study is currently recruiting participants.

Verified by Johann Wolfgang Goethe University, November 2009

First Received: November 19, 2009 No Changes Posted

Sponsor:	Johann Wolfgang Goethe University
Collaborator:	HIVCENTER
Information provided by:	Johann Wolfgang Goethe University
ClinicalTrials.gov Identifier:	NCT01017172

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 IV

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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: AIDS Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Johann Wolfgang 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:

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

Johann Wolfgang 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

No publications provided

Responsible Party:	HIVCENTER, JW Goethe University Clinic ( Markus Bickel / MD )
Study ID Numbers:	JWG11.2009
Study First Received:	November 19, 2009
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT01017172 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on February 08, 2010