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

Irina Kiseleva, Irina Isakova-Sivak, Marina Stukova, Marianna Erofeeva, Svetlana Donina, Natalie Larionova, Elena Krutikova, Ekaterina Bazhenova, Ekaterina Stepanova, Kirill Vasilyev, Victoria Matyushenko, Marina Krylova, Julia Galatonova, Aleksey Ershov, Dmitry Lioznov, Erin Grace Sparrow, Guido Torelli, Larisa Rudenko

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish
Article number296
Pages (from-to)1-20
Number of pages20
JournalVaccines
Volume8
Issue number2
DOIs
StatePublished - Jun 2020

Scopus subject areas

  • Immunology
  • Pharmacology
  • Drug Discovery
  • Infectious Diseases
  • Pharmacology (medical)

Keywords

  • Cellular immunity
  • Clinical trial
  • H7N9 influenza
  • Humoral immunity
  • Immune response
  • LAIV
  • Potential pandemic vaccine
  • Safety
  • Stability

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