Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients
Sponsor
Goethe University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01017172
Collaborator
HIVCENTER (Other)
500
1
3.9
126.8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Study Type:
Interventional
Anticipated Enrollment
:
500 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adults
Study Start Date
:
Nov 1, 2009
Anticipated Primary Completion Date
:
Mar 1, 2010
Anticipated Study Completion Date
:
Mar 1, 2010
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
written informed consent
-
age >18
-
HIV-1 infection
-
cancer
-
immunosuppressive treatment
Exclusion Criteria:
- not willing to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hivcenter | Frankfurt | Germany | 60590 |
Sponsors and Collaborators
- Goethe University
- HIVCENTER
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01017172
Other Study ID Numbers:
- JWG11.2009
First Posted:
Nov 20, 2009
Last Update Posted:
Nov 20, 2009
Last Verified:
Nov 1, 2009