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Assessment of human immune responses to H7 avian influenza virus of pandemic potential: Results from a placebo-controlled, randomized double-blind phase I study of live attenuated H7N3 influenza vaccine
2021
Introduction: Live attenuated influenza vaccines (LAIVs) are being developed to protect humans against future epidemics and pandemics. This study describes the results of a double-blinded randomized placebo-controlled phase I clinical trial of cold-adapted and temperature sensitive H7N3 live attenuated influenza vaccine candidate in healthy seronegative adults. Objective: The goal of the study was to evaluate the safety, tolerability, immunogenicity and potential shedding and transmission of H7N3 LAIV against H7 avian influenza virus of pandemic potential. Methods and Findings: Two doses of H7N3 LAIV or placebo were administered to 40 randomly divided subjects (30 received vaccine and 10 placebo). The presence of influenza A virus RNA in nasal swabs was detected in 60.0% and 51.7% of subjects after the first and second vaccination, respectively. In addition, vaccine virus was not detected among placebo recipients demonstrating the absence of person-to-person transmission. The H7N3 live attenuated influenza vaccine demonstrated a good safety profile and was well tolerated. The two-dose immunization resulted in measurable serum and local antibody production and in generation of antigen-specific CD4+ and CD8+ memory T cells. Composite analysis of the immune response which included hemagglutinin inhibition assay, microneutralization tests, and measures of IgG and IgA and virus-specific T cells showed that the majority (86.2%) of vaccine recipients developed serum and/or local antibodies responses and generated CD4+ and CD8+ memory T cells. Conclusions: The H7N3 LAIV was safe and well tolerated, immunogenic in healthy seronegative adults and elicited production of antibodies broadly reactive against the newly emerged H7N9 avian influenza virus. Trial registration: ClinicalTrials.gov NCT01511419 © 2014 Rudenko et al.
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Версии
- 1. Version of Record от 2021-04-27
Метаданные
Название журнала
- PLoS ONE
Том
- 9
Выпуск
- 2
Страницы
- -
Ключевые слова
- immunoglobulin A; immunoglobulin G; influenza vaccine; placebo; virus RNA; immunoglobulin A; immunoglobulin G; influenza vaccine; live vaccine; virus antibody; adult; antibody production; article; CD4+ T lymphocyte; CD8+ T lymphocyte; clinical assessment; clinical effectiveness; clinical evaluation; controlled study; cross reaction; double blind procedure; drug efficacy; drug safety; drug tolerability; female; hemagglutination inhibition test; human; human experiment; immune response; immunogenicity; infection prevention; influenza A; influenza vaccination; Influenza virus A H7N3; male; memory T lymphocyte; nonhuman; normal human; nose smear; pandemic; phase 1 clinical trial; randomized controlled trial; virus isolation; virus shedding; adolescent; blood; clinical trial; cold; immunology; Influenza virus A H7N9; Influenza, Human; middle aged; serodiagnosis; virus replication; young adult; Adolescent; Adult; Antibodies, Viral; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Cold Temperature; Female; Humans; Immunoglobulin A; Immunoglobulin G; Influenza A Virus, H7N3 Subtype; Influenza A Virus, H7N9 Subtype; Influenza Vaccines; Influenza, Human; Male; Middle Aged; Neutralization Tests; Vaccines, Attenuated; Virus Replication; Young Adult
Издатель
- Public Library of Science
Тип документа
- journal article
Тип лицензии Creative Commons
- CC
Правовой статус документа
- Свободная лицензия
Источник
- scopus
