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

Vaccines
Irina KiselevaLarisa Rudenko

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.

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Citations

Jul 7, 2020·JAMA : the Journal of the American Medical Association·Kevin P O'CallaghanPaul A Offit
Sep 30, 2020·Human Vaccines & Immunotherapeutics·Zhiwei JiangJielai Xia
May 1, 2021·Vaccines·Ewan P Plant, Hang Xie

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Methods Mentioned

BETA
PCR
Assay
enzyme-linked immunosorbent assay
ELISA
flow cytometry
Tem

Clinical Trials Mentioned

NCT03312231
NCT03318315
NCT03739229

Software Mentioned

R
PyroMark Assay Design
Evrogen
Kaluza Analysis
RStudio
GraphPad Prizm

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