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.
Highlights
IntroductionThe 21st century has seen the emergence and spread of a number of potentially pandemic infectious diseases, such as novel coronaviruses (SARS-CoV, MERS-CoV and SARS-CoV-2) [1] and influenza viruses of swine [2] or avian origin [3]
The 21st century has seen the emergence and spread of a number of potentially pandemic infectious diseases, such as novel coronaviruses (SARS-CoV, MERS-CoV and SARS-CoV-2) [1] and influenza viruses of swine [2] or avian origin [3].Vaccines 2020, 8, 296; doi:10.3390/vaccines8020296 www.mdpi.com/journal/vaccinesIn March 2013, the first laboratory-confirmed cases of human infection with an Asian lineage of avian influenza H7N9 in two provinces of China, Shanghai and Anhui, were detected and reported to the World Health Organization (WHO) [4]
In 2017, after analysis of H7N9 influenza activity, WHO proposed that new candidate vaccine viruses should be developed from A/Hunan/2650/2016-like (H7N9) strains of Yangtze River Delta (YRD) HA lineage [25]
Summary
The 21st century has seen the emergence and spread of a number of potentially pandemic infectious diseases, such as novel coronaviruses (SARS-CoV, MERS-CoV and SARS-CoV-2) [1] and influenza viruses of swine [2] or avian origin [3]. In 2017, after analysis of H7N9 influenza activity, WHO proposed that new candidate vaccine viruses should be developed from A/Hunan/2650/2016-like (H7N9) strains of YRD HA lineage [25]. In response to this recommendation, in 2018 we developed an LAIV candidate against human A/Hong. Kong/125/2017 strain of avian origin, a low-pathogenic A/Hunan/2650/2016-like virus, and studied its safety and immunogenicity in a ferret model [26] This was the only live influenza vaccine based on the new YRD HA lineage virus to be included in the latest WHO tables on clinical evaluation of pandemic and potential pandemic influenza vaccines in August 2019 [24]. This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 Russian LAIV based on A/Hong Kong/125/2017 candidate
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