drugset / Trial / NCT01262846
Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The overall goal of this study is to compare the safety and immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. Our hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used vaccine
Timeline
- Start
- 2010-11
- Primary completion
- 2011-04
- Completion
- 2011-04
Publications
- Background Tebas P, Frank I, Lewis M, Quinn J, Zifchak L, Thomas A, Kenney T, Kappes R, Wagner W, Maffei K, Sullivan K; Center for AIDS Research and Clinical Trials Unit of the University of Pennsylvania. Poor immunogenicity of the H1N1 2009 vaccine in well controlled HIV-infected individuals. AIDS. 2010 Sep 10;24(14):2187-92. doi: 10.1097/QAD.0b013e32833c6d5c.
- Results McKittrick N, Frank I, Jacobson JM, White CJ, Kim D, Kappes R, DiGiorgio C, Kenney T, Boyer J, Tebas P. Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial. Ann Intern Med. 2013 Jan 1;158(1):19-26. doi: 10.7326/0003-4819-158-1-201301010-00005.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza Virus Vaccine | Vaccine | 15 ug | Intramuscular |
| Subject | Influenza Virus Vaccine | Vaccine | 60 ug | Intramuscular |
| Subject | Influenza Virus Vaccine | Vaccine | 0.5 ml | Intramuscular |