TY - JOUR
T1 - A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults
AU - Talaat, Kawsar R.
AU - Greenberg, Michael E.
AU - Lai, Michael H.
AU - Hartel, Gunter F.
AU - Wichems, Christine H.
AU - Rockman, Steven
AU - Jeanfreau, Robert J.
AU - Ghosh, M. Rita
AU - Kabongo, Martin L.
AU - Gittleson, Charmaine
AU - Karron, Ruth A.
N1 - Funding Information:
Potential conflicts of interest: M.E.G., M.H.L., G.F.H., C.H.W., S.R., and C.G. are employees and hold shares of CSL Limited. R.A.K. has received research support from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH); has served as a consultant to or member of a scientific advisory board for Novartis and Novavax; and has served as a member of a data and safety monitoring board for GlaxoSmithKline. K.R.T. has received research support from NIAID, NIH. All other authors: no conflicts.
Funding Information:
Financial support: This study was sponsored by CSL Limited, with funding from the US Department of Health and Human Service’s Biomedical Advanced Research and Development Authority. The sponsor of this study did not impose any impediment, directly or indirectly, on the publication of the study’s results.
PY - 2010/11/1
Y1 - 2010/11/1
N2 - 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
AB - 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
UR - https://www.scopus.com/pages/publications/77958099793
UR - https://www.scopus.com/pages/publications/77958099793#tab=citedBy
U2 - 10.1086/656601
DO - 10.1086/656601
M3 - Article
C2 - 20874515
AN - SCOPUS:77958099793
SN - 0022-1899
VL - 202
SP - 1327
EP - 1337
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 9
ER -