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

Tracking Information

First Received Date ^ICMJE

November 19, 2009

Last Updated Date

November 19, 2009

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

HIV-1 Infection
Cancer
Immunosuppression

Intervention ^ICMJE

Other: serologic testing

Serologic testing will be performed baseline, day 21 and day 42

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

not willing to participate

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Markus Bickel, MD	+49 69 6301 7478	markus.bickel@hivcenter.de
Contact: Christoph Stephan, MD	+49 69 6301 7478	christoph.stephan@hivcenter.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01017172

Other Study ID Numbers ^ICMJE

JWG11.2009

Has Data Monitoring Committee

Responsible Party

Markus Bickel / MD, HIVCENTER, JW Goethe University Clinic

Study Sponsor ^ICMJE

Goethe University

Collaborators ^ICMJE

HIVCENTER

Investigators ^ICMJE

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

Information Provided By

Goethe University

Verification Date

November 2009

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

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