Abstract
Modern cell culture-based technology eliminates vaccine manufactures reliance on embryonated chicken eggs, which may become compromised during an avian influenza pandemic. Four studies (total N = 6230) assessed the immunogenicity and safety of mammalian cell-based, MF59®-adjuvanted, A/H5N1 vaccine (aH5N1c; AUDENZ™) as two doses administered on Days 1 and 22 in children (NCT01776554), adults (NCT01776541; NCT02839330), and older adults (NCT01766921; NCT02839330). Immunogenicity of formulations at 7.5 μg and 3.75 μg antigen per dose were assessed by hemagglutination inhibition and microneutralization assays on Days 1, 22, 43, and 183 or 387. Solicited local and systemic adverse events (AEs) were recorded for 7 days after each vaccination. Unsolicited AEs were collected for 21 days after each vaccination, and serious and other selected AEs were recorded for one year. Antibody responses after two 7.5 μg doses met CBER licensure criteria in all age groups. Overall, an age-related response was evident, with the highest responses observed in children <3 years old. In children, antibody titers met seroconversion criteria 12 months after vaccination. MF59 allowed for antigen dose sparing. Solicited AEs were mild to moderate in nature, of short duration, and less frequent after the second dose than the first, demonstrating a favorable risk-benefit profile.
Highlights
In recent history, major influenza pandemics occurred in 1918 (A/H1N1), 1957 (A/H2N2), 1968 (A/H3N2), and 2009 (A/H1N1), these events resulted in approximately 45, 1.5, 1.3, and 0.6 million human deaths, respectively [1]
Three A/H5N1 vaccines are licensed by the U.S Food and Drug Administration for possible use during a future pandemic, all of which are manufactured using traditional egg-based technology [3]
The assessment of a ( U.S licensed) mammalian cell-based, A/H5N1, pandemic vaccine described in this report was conducted as part of a program designed by Seqirus USA Inc. (Cambridge, MA, USA) in partnership with the U.S Biomedical Advanced Research and Development Authority (BARDA) to develop a cell-based vaccine to support national and international pandemic preparedness needs
Summary
Major influenza pandemics occurred in 1918 (A/H1N1), 1957 (A/H2N2), 1968 (A/H3N2), and 2009 (A/H1N1), these events resulted in approximately 45, 1.5, 1.3, and 0.6 million human deaths, respectively [1]. In the event of an outbreak, very few people would possess pandemic strain-specific memory lymphocyte populations and would have no immunity to the virus. Pandemic preparedness strategy includes the preparation and licensing of pandemic influenza vaccines in advance of any future pandemic, thereby significantly decreasing the amount of time required to develop and deliver vaccine during the critical early stages of an outbreak. The assessment of a ( U.S licensed) mammalian cell-based, A/H5N1, pandemic vaccine described in this report was conducted as part of a program designed by Seqirus USA Inc. (Cambridge, MA, USA) in partnership with the U.S Biomedical Advanced Research and Development Authority (BARDA) to develop a cell-based vaccine to support national and international pandemic preparedness needs The assessment of a ( U.S licensed) mammalian cell-based, A/H5N1, pandemic vaccine described in this report was conducted as part of a program designed by Seqirus USA Inc. (Cambridge, MA, USA) in partnership with the U.S Biomedical Advanced Research and Development Authority (BARDA) to develop a cell-based vaccine to support national and international pandemic preparedness needs
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