Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients
Phase 4
- Conditions
- HIV-1 InfectionCancerImmunosuppression
- 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.
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 potential adverse reactions of the H1N1 vaccine baseline, day 21, day 42 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
Trial Locations
- Locations (1)
Hivcenter
🇩🇪Frankfurt, Germany