About: A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults

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About: A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults 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	A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults
Creator	Kiseleva, Irina Larionova, Natalie Sparrow, Erin Stukova, Marina Bazhenova, Ekaterina Donina, Svetlana Erofeeva, Marianna Ershov, Aleksey Galatonova, Julia Isakova-Sivak, Irina Krutikova, Elena Krylova, Marina Lioznov, Dmitry Matyushenko, Victoria Rudenko, Larisa Stepanova, Ekaterina Torelli, Guido Vasilyev, Kirill
Source	Medline; PMC
abstract	This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 live attenuated influenza vaccine (LAIV) based on the human influenza virus of Yangtze River Delta hemagglutinin lineage (ClinicalTrials.gov Identifier: NCT03739229). Two doses of H7N9 LAIV or placebo were administered intranasally to 30 and 10 subjects, respectively. The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events. Vaccine virus was detected in nasal swabs during the 6 days after vaccination or revaccination. A lower frequency of shedding was observed after the second vaccination. Twenty-five clinical viral isolates obtained after the first and second doses of vaccine retained the temperature-sensitive and cold-adapted phenotypic characteristics of LAIV. There was no confirmed transmission of the vaccine strain from vaccinees to placebo recipients. After the two H7N9 LAIV doses, an immune response was observed in 96.6% of subjects in at least one of the assays conducted.
has issue date	2020-06-10(xsd:dateTime)
bibo:doi	10.3390/vaccines8020296
bibo:pmid	32532097
has license	cc-by
sha1sum (hex)	42e1a4130ac4fa5705c7e6ed5aeda72df3eeecaa
schema:url	https://doi.org/10.3390/vaccines8020296
resource representing a document's title	A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults
has PubMed Central identifier	PMC7350028
has PubMed identifier	32532097
schema:publication	Vaccines (Basel)
resource representing a document's body	covid:42e1a4130ac4fa5705c7e6ed5aeda72df3eeecaa#body_text
is schema:about of	named entity 'DOUBLE' named entity 'COLD' named entity 'BLIND' named entity 'TRANSMISSION' named entity 'ADMINISTERED' named entity 'ADAPTED' named entity 'REVACCINATION' named entity 'NASAL SWABS' named entity 'IMMUNE RESPONSE' named entity 'LAIV' named entity 'vaccine' named entity 'adverse events' named entity 'placebo' named entity 'Live Attenuated Influenza Vaccine' named entity 'placebo' named entity 'IgA' named entity 'Hunan' named entity 'phenotypic' named entity 'virus' named entity 'CD4' named entity 'epidemic' named entity 'H7N9' named entity 'amino acid' named entity 'LAIV' named entity 'lymphocytes' named entity 'LAIV' named entity 'LAIV' named entity 'mucosal' named entity 'Global Influenza Pandemic' named entity 'gene' named entity 'immune response' named entity 'LAIV' named entity 'enzyme-linked immunosorbent assay' named entity 'PBS' named entity 'live attenuated' named entity 'H7N7' named entity 'CD4' named entity 'vaccination' named entity 'nasal swab' named entity 'LAIV' named entity 'mutation rate' named entity 'T-cell' named entity 'CD8 +' named entity 'virus' named entity 'virus' named entity 'vaccine' named entity 'virus' named entity 'adverse reactions' named entity 'vaccine' named entity 'IgA antibody' named entity 'H7N9' named entity 'serum' named entity 'lymphocytes' named entity 'physical examination' named entity 'clinical evaluation' named entity 'antigen' named entity 'PBS' named entity 'drug therapy' named entity 'Antibody titer' named entity 'H7N9' named entity 'AEs' named entity 'LAIV' named entity 'virus' named entity 'avian influenza viruses'

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