About: Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant

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About: Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin 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	Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant
Creator	Honda-Okubo, Yoshikazu Petrovsky, Nikolai Barr, Ian Gordon, David Sajkov, Dimitar Aban, Malet Wilks, Samuel
Source	Elsevier; Medline; PMC
abstract	Influenza vaccines are usually non-adjuvanted but addition of adjuvant may improve immunogenicity and permit dose-sparing, critical for vaccine supply in the event of an influenza pandemic. The aim of this first-in-man study was to determine the effect of delta inulin adjuvant on the safety and immunogenicity of a reduced dose seasonal influenza vaccine. Healthy male and female adults aged 18–65 years were recruited to participate in a randomized controlled study to compare the safety, tolerability and immunogenicity of a reduced-dose 2007 Southern Hemisphere trivalent inactivated influenza vaccine formulated with Advax™ delta inulin adjuvant (LTIV + Adj) when compared to a full-dose of the standard TIV vaccine which does not contain an adjuvant. LTIV + Adj provided equivalent immunogenicity to standard TIV vaccine as assessed by hemagglutination inhibition (HI) assays against each vaccine strain as well as against a number of heterosubtypic strains. HI responses were sustained at 3 months post-immunisation in both groups. Antibody landscapes against a large panel of H3N2 influenza viruses showed distinct age effects whereby subjects over 40 years old had a bimodal baseline HI distribution pattern, with the highest HI titers against the very oldest H3N2 isolates and with a second HI peak against influenza isolates from the last 5–10 years. By contrast, subjects >40 years had a unimodal baseline HI distribution with peak recognition of H3N2 isolates from approximately 20 years ago. The reduced dose TIV vaccine containing Advax adjuvant was well tolerated and no safety issues were identified. Hence, delta inulin may be a useful adjuvant for use in seasonal or pandemic influenza vaccines. Australia New Zealand Clinical Trial Registry: ACTRN12607000599471
has issue date	2016-07-01(xsd:dateTime)
bibo:doi	10.1016/j.vaccine.2016.05.071
bibo:pmid	27342914
has license	green-oa
sha1sum (hex)	59932fb1f0b98d054deab83dbf18caa8396cb6e8
schema:url	https://doi.org/10.1016/j.vaccine.2016.05.071
resource representing a document's title	Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant
has PubMed Central identifier	PMC4949042
has PubMed identifier	27342914
schema:publication	Vaccine
resource representing a document's body	covid:59932fb1f0b98d054deab83dbf18caa8396cb6e8#body_text
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