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  • Title: Responses after one dose of a monovalent influenza A (H1N1) 2009 inactivated vaccine in Chinese population--a practical observation.
    Author: Sun F, Zhang Y, Tian D, Zheng M, Liu L, Zhang R, Dai Z, Chen J, Li T, Lu H.
    Journal: Vaccine; 2011 Sep 02; 29(38):6527-31. PubMed ID: 21767595.
    Abstract:
    BACKGROUND: The globally large-scale immunization was the most important method of controlling the 2009 pandemic influenza. METHODS: We conducted an observational clinical trial, including 148 adults aged 18-60 years to evaluate the safety and immunogenicity of a licensed 2009 H1N1 influenza vaccine. All subjects received a single 15-μg dose of a monovalent, unadjuvanted inactivated vaccine. Antibody titers were measured by means of hemagglutinin-inhibition assays and neutralization assays based on Real-Time Cell Analyzer (RTCA) instruments at baseline, 7 days and 21 days after vaccination. RESULTS: Local and systemic reactions were respectively reported by 19.1% and 22.1% of subjects. All adverse events were mild to moderate in intensity, without any deaths or serious events. By day 21 after vaccination, hemagglutinin-inhibition antibody titers of 1:40 or more were achieved in 101 of 123 (82.1%) subjects and the geometric mean titers (GMTs) increased to 1:95.27. For neutralization assays, all subjects could provide the protection against wide influenza virus, with the GMT of 1:525.44. Moreover, the rates of seroconversion, as measured using hemagglutinin-inhibition assays and neutralization assays, were 73.98% and 91.87% of subjects, respectively. CONCLUSIONS: A single 15-μg dose of a monovalent, unadjuvanted inactivated 2009 H1N1 influenza vaccine was well tolerated, and induced a protective immune response in the majority of subjects aged 18-60 years (clinical trials gov number, NCT01055990).
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