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Open AccessArticle

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

1
Federal State Budgetary Scientific Institution “Institute of Experimental Medicine”, 197376 St Petersburg, Russia
2
Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia
3
The Federal State Unitary Enterprise “Scientific and Production Association for Immunological Preparations “Microgen”, Ministry of Health of Russian Federation, 127473 Moscow, Russia
4
World Health Organization, 1211 Geneva, Switzerland
*
Author to whom correspondence should be addressed.
Vaccines 2020, 8(2), 296; https://doi.org/10.3390/vaccines8020296
Received: 1 May 2020 / Revised: 30 May 2020 / Accepted: 9 June 2020 / Published: 10 June 2020
(This article belongs to the Special Issue Influenza Virus and Vaccine Development)
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. View Full-Text
Keywords: H7N9 influenza; potential pandemic vaccine; LAIV; clinical trial; safety; stability; immune response; humoral immunity; cellular immunity H7N9 influenza; potential pandemic vaccine; LAIV; clinical trial; safety; stability; immune response; humoral immunity; cellular immunity
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Kiseleva, I.; Isakova-Sivak, I.; Stukova, M.; Erofeeva, M.; Donina, S.; Larionova, N.; Krutikova, E.; Bazhenova, E.; Stepanova, E.; Vasilyev, K.; Matyushenko, V.; Krylova, M.; Galatonova, J.; Ershov, A.; Lioznov, D.; Sparrow, E.G.; Torelli, G.; Rudenko, L. 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 2020, 8, 296.

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