tetano
Editor, Senior Moderator
J Infect Dis. 2010 Sep 28. [Epub ahead of print]
A Single Dose of Unadjuvanted Novel 2009 H1N1 Vaccine Is Immunogenic and Well Tolerated in Young and Elderly Adults.
Talaat KX, Greenberg MX, Lai MX, Hartel GX, Wichems CX, Rockman S, Jeanfreau RX, Ghosh MX, Kabongo MX, Gittleson C, Karron RX.
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, and 2Accelovance, Rockville, Maryland; 3Benchmark Research, Austin, Texas; 4Department of Family and Preventative Medicine, University of California, San Diego, La Jolla; 5Clinical Research and Development, CSL Limited, Parkville, Victoria, Australia.
Abstract
Background. When the novel H1N1 influenza A strain appeared in April of 2009, development of novel H1N1 vaccines became a public health priority. Methods. We conducted a phase‐2, multicenter, randomized, placebo‐controlled, observer‐blind clinical trial of a 2009 H1N1 vaccine in 1313 young (age, 18–64 years) and older (age, ⩾65 years) adults. Participants were randomized 1:4:4:4 to receive 2 doses of placebo or 7.5, 15, or 30 μg of H1N1 hemagglutinin administered 21 days apart. In post hoc analyses, hemagglutination inhibition (HI) titers measured at baseline and after vaccination were analyzed for young adults (age, 18–64 years), “younger elderly” adults (age, 65–74 years), and “very elderly” adults (age, ⩾75 years). Results. At baseline, 28.8% of young adults, 43.9% of younger elderly adults, and 62.9% of very elderly adults had HI titers to A/2009 H1N1 of ⩾1:40. A single 7.5‐μg dose induced HI titers ⩾1:40 in 94.5% (95% confidence interval [CI], 91.8%–96.3%) of all adults. After one 7.5‐μg dose, the geometric mean titers achieved were 326.4 (95% CI, 275.9–386.0) in young adults, 155.4 (95% CI, 123.4–195.8) in “younger elderly” adults, and 243.9 (95% CI, 167.1–356.0) in “very elderly” adults. Conclusions. This large phase‐2 trial demonstrated that a single 7.5‐μg dose of a monovalent unadjuvanted H1N1 vaccine induced protective HI antibody levels in adults of all ages, including very elderly adults. Trial registration. Clinicaltrials.gov identifier NCT00958126.
PMID: 20874515 [PubMed - as supplied by publisher]
http://www.flutrackers.com/forum/newthread.php?do=newthread&f=712
A Single Dose of Unadjuvanted Novel 2009 H1N1 Vaccine Is Immunogenic and Well Tolerated in Young and Elderly Adults.
Talaat KX, Greenberg MX, Lai MX, Hartel GX, Wichems CX, Rockman S, Jeanfreau RX, Ghosh MX, Kabongo MX, Gittleson C, Karron RX.
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, and 2Accelovance, Rockville, Maryland; 3Benchmark Research, Austin, Texas; 4Department of Family and Preventative Medicine, University of California, San Diego, La Jolla; 5Clinical Research and Development, CSL Limited, Parkville, Victoria, Australia.
Abstract
Background. When the novel H1N1 influenza A strain appeared in April of 2009, development of novel H1N1 vaccines became a public health priority. Methods. We conducted a phase‐2, multicenter, randomized, placebo‐controlled, observer‐blind clinical trial of a 2009 H1N1 vaccine in 1313 young (age, 18–64 years) and older (age, ⩾65 years) adults. Participants were randomized 1:4:4:4 to receive 2 doses of placebo or 7.5, 15, or 30 μg of H1N1 hemagglutinin administered 21 days apart. In post hoc analyses, hemagglutination inhibition (HI) titers measured at baseline and after vaccination were analyzed for young adults (age, 18–64 years), “younger elderly” adults (age, 65–74 years), and “very elderly” adults (age, ⩾75 years). Results. At baseline, 28.8% of young adults, 43.9% of younger elderly adults, and 62.9% of very elderly adults had HI titers to A/2009 H1N1 of ⩾1:40. A single 7.5‐μg dose induced HI titers ⩾1:40 in 94.5% (95% confidence interval [CI], 91.8%–96.3%) of all adults. After one 7.5‐μg dose, the geometric mean titers achieved were 326.4 (95% CI, 275.9–386.0) in young adults, 155.4 (95% CI, 123.4–195.8) in “younger elderly” adults, and 243.9 (95% CI, 167.1–356.0) in “very elderly” adults. Conclusions. This large phase‐2 trial demonstrated that a single 7.5‐μg dose of a monovalent unadjuvanted H1N1 vaccine induced protective HI antibody levels in adults of all ages, including very elderly adults. Trial registration. Clinicaltrials.gov identifier NCT00958126.
PMID: 20874515 [PubMed - as supplied by publisher]
http://www.flutrackers.com/forum/newthread.php?do=newthread&f=712