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Статья
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
2021
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. © 2020 by the authors. Licensee MDPI, Basel, Switzerland.
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Версии
- 1. Version of Record от 2021-04-27
Метаданные
Название журнала
- Vaccines
Том
- 8
Выпуск
- 2
Страницы
- 1-20
Ключевые слова
- immunoglobulin A antibody; immunoglobulin G antibody; influenza vaccine; Influenza virus hemagglutinin; placebo; virus RNA; adult; antibody blood level; antibody titer; Article; CD4+ T lymphocyte; CD8+ T lymphocyte; cellular immunity; controlled study; coughing; double blind procedure; drug safety; fatigue; female; fever; genetic stability; herpes simplex; human; human experiment; influenza A (H7N9); Influenza A virus (H7N9); influenza vaccination; malaise; male; normal human; nose obstruction; nose smear; peripheral blood mononuclear cell; phase 1 clinical trial; phenotype; randomized controlled trial; real time polymerase chain reaction; real time reverse transcription polymerase chain reaction; revaccination; sore throat; vaccine immunogenicity; virus isolation; virus shedding; virus transmission
Издатель
- MDPI AG
Тип документа
- journal article
Тип лицензии Creative Commons
- CC
Правовой статус документа
- Свободная лицензия
Источник
- scopus
