Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adults
18 Years
N/A
Both
HIV-1 Infection, Cancer, Immunosuppression
Trial Information
Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adults
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.
Inclusion Criteria:
- written informed consent
- age >18
- HIV-1 infection
- cancer
- immunosuppressive treatment
Exclusion Criteria:
- not willing to participate
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients
Outcome Time Frame:
baseline, day 21, day 42
Safety Issue:
No
Principal Investigator
Markus Bickel, MD
Investigator Role:
Study Director
Investigator Affiliation:
JW Goethe University Clinic
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
JWG11.2009
NCT ID:
NCT01017172
Start Date:
November 2009
Completion Date:
March 2010
Related Keywords:
- HIV-1 Infection
- Cancer
- Immunosuppression
- Influenza, Human
- HIV Infections
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