【文章名】Safety and Long-term Humoral Immune Response in Adults After Vaccination With an H1N1 2009 Pandemic Influenza Vaccine With or Without AS03 Adjuvant
[摘要]：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-mu g HA/AS03(A) or 1.9-mu g HA/AS03(B)) 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 AS03(A)-adjuvanted 3.75-mu g HA H1N1 2009 induced the strongest immune responses in subjects aged 18264 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-mu g 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-mu g HA AS03(A)-adjuvanted H1N1 2009 influenza vaccine was highly immunogenic in both age strata (18264 and >64 years), inducing long-term persistence of the immune response until at least 6 months after dose 1.
