tetano
Editor, Senior Moderator
Clin Vaccine Immunol. 2011 Jun 29. [Epub ahead of print]
Immunogenicity and Safety of Influenza A/H1N1 2009 Inactivated Split-Virus Vaccine in Young and Older Adults: MF59 Adjuvanted Vaccine Versus Nonadjuvanted Vaccine.
Cheong HJ, Song JY, Heo JY, Noh JY, Choi WS, Park DW, Wie SH, Kim WJ.
Source
Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine.
Abstract
Since initial reports in April 2009, the pandemic influenza A (H1N1) virus has spread globally. Influenza vaccines are the primary method for the control of influenza and its complications. We conducted a multicenter clinical trial to evaluate the immunogenicity and safety of H1N1 vaccine in young adults (18-64 years) and the elderly (≥65 years) using a two-dose regimen, administered 21 days apart. Three different regimens of hemagglutinin antigen were comparatively analyzed: 3.75 μg (MF59 adjuvanted) versus 7.5 μg (MF59 adjuvanted) versus 15 μg (nonadjuvanted) in young adults and 3.75 μg (MF59 adjuvanted) versus 7.5 μg (MF59 adjuvanted) in the elderly. In young adults, all three vaccine regimens met the European Agency for the Evaluation of Medicinal Products (EMA) criteria after the first dose. In the elderly, on day 21 after the first dose, the rates of seroprotection and seroconversion were significantly higher for the 7.5-μg dose of MF59 adjuvanted vaccine than the 3.75-μg dose (58.0% vs. 44.3%, P = 0.03 and 53.7% vs. 37.2%, P < 0.01, respectively). After the second dose, the geometric mean titer (GMT) increment was blunted with a 15-μg dose of nonadjuvanted vaccine, whereas the GMT increased about 2-fold with MF59 adjuvanted vaccines. In conclusion, a single 7.5-μg dose of MF59 adjuvanted vaccine would have a practical advantage over a two-dose, 3.75-μg, MF59 adjuvanted vaccine priming schedule. Following two-dose priming schedule, the increase in hemagglutinin inhibition titers was higher with MF59 adjuvanted vaccine compared to nonadjuvanted vaccine.
PMID:
21715575
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21715575
Immunogenicity and Safety of Influenza A/H1N1 2009 Inactivated Split-Virus Vaccine in Young and Older Adults: MF59 Adjuvanted Vaccine Versus Nonadjuvanted Vaccine.
Cheong HJ, Song JY, Heo JY, Noh JY, Choi WS, Park DW, Wie SH, Kim WJ.
Source
Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine.
Abstract
Since initial reports in April 2009, the pandemic influenza A (H1N1) virus has spread globally. Influenza vaccines are the primary method for the control of influenza and its complications. We conducted a multicenter clinical trial to evaluate the immunogenicity and safety of H1N1 vaccine in young adults (18-64 years) and the elderly (≥65 years) using a two-dose regimen, administered 21 days apart. Three different regimens of hemagglutinin antigen were comparatively analyzed: 3.75 μg (MF59 adjuvanted) versus 7.5 μg (MF59 adjuvanted) versus 15 μg (nonadjuvanted) in young adults and 3.75 μg (MF59 adjuvanted) versus 7.5 μg (MF59 adjuvanted) in the elderly. In young adults, all three vaccine regimens met the European Agency for the Evaluation of Medicinal Products (EMA) criteria after the first dose. In the elderly, on day 21 after the first dose, the rates of seroprotection and seroconversion were significantly higher for the 7.5-μg dose of MF59 adjuvanted vaccine than the 3.75-μg dose (58.0% vs. 44.3%, P = 0.03 and 53.7% vs. 37.2%, P < 0.01, respectively). After the second dose, the geometric mean titer (GMT) increment was blunted with a 15-μg dose of nonadjuvanted vaccine, whereas the GMT increased about 2-fold with MF59 adjuvanted vaccines. In conclusion, a single 7.5-μg dose of MF59 adjuvanted vaccine would have a practical advantage over a two-dose, 3.75-μg, MF59 adjuvanted vaccine priming schedule. Following two-dose priming schedule, the increase in hemagglutinin inhibition titers was higher with MF59 adjuvanted vaccine compared to nonadjuvanted vaccine.
PMID:
21715575
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21715575