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

Goethe University1 site in 1 country500 target enrollmentNovember 2009

ConditionsHIV-1 Infection Cancer Immunosuppression

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: HIV-1 Infection
Sponsor: Goethe University
Enrollment: 500
Locations: 1
Primary Endpoint: To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

March 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Goethe University

Eligibility Criteria

Inclusion Criteria

•written informed consent
•HIV-1 infection
•immunosuppressive treatment

Exclusion Criteria

•not willing to participate

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)