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    Vaccine. 2009 Nov 5;27(47):6642-8. Epub 2009 Mar 25.

    Safety and immunogenicity of inactivated, Vero cell culture-derived whole virus influenza A/H5N1 vaccine given alone or with aluminum hydroxide adjuvant in healthy adults.

    Keitel WA, Dekker CL, Mink C, Campbell JD, Edwards KM, Patel SM, Ho DY, Talbot HK, Guo K, Noah DL, Hill H.

    Source

    Baylor College of Medicine Vaccine Research Center, Houston, TX 77030, USA. wkeitel@bcm.edu

    Abstract

    Dosage-sparing strategies, adjuvants and alternative substrates for vaccine production are being explored for influenza vaccine development. We assessed the safety and immunogenicity of a Vero cell culture-grown inactivated whole virus influenza A/H5N1 vaccine with or without aluminum hydroxide adjuvant [Al(OH)(3)] in healthy young adults. Vaccines were well tolerated, but injection site discomfort was more frequent in groups receiving Al(OH)(3). Dose-related increases in serum antibody levels were observed. Neutralizing antibody titers varied significantly when tested by two different laboratories. Al(OH)(3) did not enhance HAI or neutralizing antibody responses, and contributed to increased injection site pain. Because influenza antibody titers vary significantly between different laboratories, international standardization of assays is warranted.

    PMID:
    19773098
    [PubMed - indexed for MEDLINE]
    PMCID:
    PMC3022490
    Free PMC Article

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