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- Title
Safety and Long-term Humoral Immune Response in Adults After Vaccination With an H1N1 2009 Pandemic Influenza Vaccine With or Without AS03 Adjuvant.
- Authors
Ferguson, Murdo; Risi, George; Davis, Matthew; Sheldon, Eric; Baron, Mira; Ping Li; Madariaga, Miguel; Fries, Louis; Godeaux, Olivier; Vaughn, David
- Abstract
Background. In this study (NCT00985088) we evaluated different formulations of an H1N1 2009 pandemic influenza vaccine that deliver various viral hemagglutinin (HA) doses with or without AS03 (a tocopherol-based oil-in-water adjuvant system). Methods. A total of 1340 healthy subjects aged ≤18 years were randomized to receive 1 or 2 doses of an adjuvanted (3.75-lg HA/AS03A or 1.9-μg HA/AS03B) or nonadjuvanted vaccine formulation. Safety and immunogenicity (by hemagglutination-inhibition [HI] assay) after each dose and 6 months after dose 1 are reported here. Results. A single dose of AS03A-adjuvanted 3.75-μg HA H1N1 2009 induced the strongest immune responses in subjects aged 18-64 years (seroprotection rate [SPR], 97.2%; seroconversion rate [SCR], 90.1%) as well as in subjects aged >64 years (SPR, 91.1%; SCR, 78.2%) 21 days after vaccination. Six months after dose 1, subjects who received 2 doses of either the adjuvanted formulation or 1 dose of the adjuvanted 3.75-μg HA formulation continued to meet all Center for Biologics Evaluation and Research and Committee for Medicinal Products for Human Use criteria. All formulations had clinically acceptable safety profiles Conclusion. A single dose of the 3.75-lg HA AS03A-adjuvanted H1N1 2009 influenza vaccine was highly immunogenic in both age strata (18-64 and >64 years), inducing long-term persistence of the immune response until at least 6 months after dose 1.
- Subjects
IMMUNE response; H1N1 influenza; HEMAGGLUTININ; IMMUNOLOGICAL adjuvants; VITAMIN E; IMMUNODIFFUSION; VACCINATION
- Publication
Journal of Infectious Diseases, 2012, Vol 205, Issue 5, p733
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jir641