About: Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant

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About: Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant Goto Sponge NotDistinct Permalink

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Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant
Creator	Edwards, Kathryn Chen, Wilbur Creech, C Kotloff, Karen Keitel, Wendy Jackson, Lisa Hill, Heather Patel, Shital Mangal, Brian Noah, Diana
Source	PMC
abstract	BACKGROUND: The national stockpile for influenza pandemic preparedness includes vaccines against an array of strains and adjuvants that could be utilized to induce immunologic priming as a pandemic wave emerges. We assessed the feasibility of a strategy that allows the flexibility of postmanufacture mixture of vaccine and adjuvant at the point of care. METHODS: We conducted a randomized, double-blind, multicenter trial among healthy adults aged 18–49 years who received 2 doses of inactivated influenza A/Indonesia/05/2005 (H5N1 clade 2.2.3) virus vaccine containing either 3.75, 7.5, or 15 µg of hemagglutinin (HA) with or without AS03 adjuvant, administered 21 days apart. Subjects were observed for local (injection site) and systemic reactogenicity and adverse events. Sera were tested for hemagglutination inhibition (HAI) and microneutralization (MN) antibody levels against the homologous strain and 4 heterologous avian strains. RESULTS: Vaccine containing ASO3 adjuvant was associated with significantly more local reactions compared with nonadjuvanted vaccine, but these were short-lived and resolved spontaneously. Although the immune response to nonadjuvanted vaccine was poor, 2 doses of AS03-adjuvanted vaccine containing as little as 3.75 µg of HA elicited robust immune responses resulting in seroprotective titers (≥1:40) to the homologous strain in ≥86% of subjects by HAI and in 95% of subjects by MN. Cross-clade antibody responses were also observed with AS03-adjuvanted vaccine, but not nonadjuvanted vaccine. CONCLUSIONS: AS03 adjuvant formulated with inactivated vaccine at the administration site significantly enhanced the immune responses to H5N1 vaccine and has the potential to markedly improve vaccine responses and accelerate delivery during an influenza pandemic. CLINICAL TRIALS REGISTRATION: NCT01317758.
has issue date	2014-10-08(xsd:dateTime)
bibo:doi	10.1093/ofid/ofu091
bibo:pmid	25734159
has license	cc-by-nc-nd
sha1sum (hex)	5131bb2d2d88e7b18bf2607c579daeb01e263e6a
schema:url	https://doi.org/10.1093/ofid/ofu091
resource representing a document's title	Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant
has PubMed Central identifier	PMC4324222
has PubMed identifier	25734159
schema:publication	Open Forum Infect Dis
resource representing a document's body	covid:5131bb2d2d88e7b18bf2607c579daeb01e263e6a#body_text
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