tetano
Editor, Senior Moderator
Vaccines (Basel)
. 2020 Jun 10;8(2):E296.
doi: 10.3390/vaccines8020296.
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[SUP] 1 [/SUP], Irina Isakova-Sivak[SUP] 1 [/SUP], Marina Stukova[SUP] 2 [/SUP], Marianna Erofeeva[SUP] 2 [/SUP], Svetlana Donina[SUP] 1 [/SUP], Natalie Larionova[SUP] 1 [/SUP], Elena Krutikova[SUP] 1 [/SUP], Ekaterina Bazhenova[SUP] 1 [/SUP], Ekaterina Stepanova[SUP] 1 [/SUP], Kirill Vasilyev[SUP] 2 [/SUP], Victoria Matyushenko[SUP] 1 [/SUP], Marina Krylova[SUP] 3 [/SUP], Julia Galatonova[SUP] 3 [/SUP], Aleksey Ershov[SUP] 3 [/SUP], Dmitry Lioznov[SUP] 2 [/SUP], Erin Grace Sparrow[SUP] 4 [/SUP], Guido Torelli[SUP] 4 [/SUP], Larisa Rudenko[SUP] 1 [/SUP]
Affiliations
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.
Keywords: H7N9 influenza; LAIV; cellular immunity; clinical trial; humoral immunity; immune response; potential pandemic vaccine; safety; stability.
. 2020 Jun 10;8(2):E296.
doi: 10.3390/vaccines8020296.
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[SUP] 1 [/SUP], Irina Isakova-Sivak[SUP] 1 [/SUP], Marina Stukova[SUP] 2 [/SUP], Marianna Erofeeva[SUP] 2 [/SUP], Svetlana Donina[SUP] 1 [/SUP], Natalie Larionova[SUP] 1 [/SUP], Elena Krutikova[SUP] 1 [/SUP], Ekaterina Bazhenova[SUP] 1 [/SUP], Ekaterina Stepanova[SUP] 1 [/SUP], Kirill Vasilyev[SUP] 2 [/SUP], Victoria Matyushenko[SUP] 1 [/SUP], Marina Krylova[SUP] 3 [/SUP], Julia Galatonova[SUP] 3 [/SUP], Aleksey Ershov[SUP] 3 [/SUP], Dmitry Lioznov[SUP] 2 [/SUP], Erin Grace Sparrow[SUP] 4 [/SUP], Guido Torelli[SUP] 4 [/SUP], Larisa Rudenko[SUP] 1 [/SUP]
Affiliations
- PMID: 32532097
- DOI: 10.3390/vaccines8020296
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.
Keywords: H7N9 influenza; LAIV; cellular immunity; clinical trial; humoral immunity; immune response; potential pandemic vaccine; safety; stability.