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

Phase 4

• Conditions: HIV-1 Infection; Cancer; Immunosuppression

• Registration Number: NCT01017172
• Lead Sponsor: Goethe University

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 Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Last Update Submitted: 2009-11-19
• Study First Posted: 2009-11-20
• Last Update Posted: 2009-11-20
• Primary Completion: 2010-03
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• not willing to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients	baseline, day 21, day 42

Secondary Outcome Measures

Name	Time	Method
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	baseline
To evaluate potential adverse reactions of the H1N1 vaccine	baseline, day 21, day 42

Trial Locations

Locations (1)

Hivcenter; 🇩🇪 Frankfurt, Germany