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| Name | Class |
|---|---|
| HIVCENTER | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serologic testing | Other | Serologic testing will be performed baseline, day 21 and day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Markus Bickel, MD | Contact | +49 69 6301 7478 | markus.bickel@hivcenter.de | |
| Christoph Stephan, MD | Contact | +49 69 6301 7478 | christoph.stephan@hivcenter.de |
| Name | Affiliation | Role |
|---|---|---|
| Markus Bickel, MD | JW Goethe University Clinic | Study Director |
| Christoph Stephan, MD | JW Goethe University Clinic | Study Chair |
| Hans R Brodt, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hivcenter | Recruiting | Frankfurt | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23924590 | Derived | Bickel M, Lassmann C, Wieters I, Doerr HW, Herrmann E, Wicker S, Brodt HR, Stephan C, Allwinn R, Jung O. Immune response after a single dose of the 2010/11 trivalent, seasonal influenza vaccine in HIV-1-infected patients and healthy controls. HIV Clin Trials. 2013 Jul-Aug;14(4):175-81. doi: 10.1310/hct1404-175. | |
| 21324375 | Derived |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| JW Goethe University Clinic |
| Principal Investigator |
| Gueller S, Allwinn R, Mousset S, Martin H, Wieters I, Herrmann E, Serve H, Bickel M, Bug G. Enhanced immune response after a second dose of an AS03-adjuvanted H1N1 influenza A vaccine in patients after hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2011 Oct;17(10):1546-50. doi: 10.1016/j.bbmt.2011.02.004. Epub 2011 Feb 13. |
| 21148530 | Derived | Bickel M, von Hentig N, Wieters I, Khaykin P, Nisius G, Haberl A, Stephan C, Herrmann E, Doerr HW, Brodt HR, Allwinn R. Immune response after two doses of the novel split virion, adjuvanted pandemic H1N1 influenza A vaccine in HIV-1-infected patients. Clin Infect Dis. 2011 Jan 1;52(1):122-7. doi: 10.1093/cid/ciq003. |
| 20559034 | Derived | Bickel M, Wieters I, Khaykin P, Nisius G, Haberl A, Stephan C, Von Hentig N, Herrmann E, Doerr HW, Brodt HR, Allwinn R. Low rate of seroconversion after vaccination with a split virion, adjuvanted pandemic H1N1 influenza vaccine in HIV-1-infected patients. AIDS. 2010 Jun 1;24(9):F31-5. doi: 10.1097/QAD.0b013e3283398da1. |