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Статья
H2N2 live attenuated influenza vaccine is safe and immunogenic for healthy adult volunteers
2021
H2N2 influenza viruses have not circulated in the human population since 1968, but they are still being regularly detected in the animal reservoir, suggesting their high pandemic potential. To prepare for a possible H2N2 pandemic, a number of H2N2 vaccine candidates have been generated and tested in preclinical and clinical studies. Here we describe the results of a randomized, double-blind placebo-controlled phase 1 clinical trial of an H2N2 live attenuated influenza vaccine (LAIV) candidate prepared from a human influenza virus isolated in 1966. The vaccine candidate was safe and well-tolerated by healthy adults, and did not cause serious adverse events or an increased rate of moderate or severe reactogenicities. The H2N2 vaccine virus was infectious for Humans. It was shed by 78.6% and 74.1% volunteers after the first and second dose, respectively, most probably due to the human origin of the virus. Importantly, no vaccine virus transmission to unvaccinated subjects was detected during the study. We employed multiple immunological tests to ensure the adequate assessment of the H2N2 pandemic LAIV candidate and demonstrated that the majority (92.6%) of the vaccinated subjects responded to the H2N2 LAIV in one or more immunological tests, including 85.2% of subjects with antibody responses and 55.6% volunteers with cell-mediated immune responses. In addition, we observed strong correlation between the H2N2 LAIV virus replication in the upper respiratory tract and the development of antibody responses. © 2015 Taylor & Francis Group, LLC.
Цитирование
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Версии
- 1. Version of Record от 2021-04-27
Метаданные
Название журнала
- Human Vaccines and Immunotherapeutics
Том
- 11
Выпуск
- 4
Страницы
- 970-982
Ключевые слова
- alanine aminotransferase; aspartate aminotransferase; bicarbonate; bilirubin; calcium; gamma interferon; glucose; immunoglobulin A antibody; immunoglobulin G antibody; influenza vaccine; placebo; influenza vaccine; adult; animal cell; antibody response; Article; CD4 lymphocyte count; CD8+ T lymphocyte; cellular immunity; chick embryo; controlled study; double blind procedure; drug safety; drug tolerability; dry nose; ear congestion; ear disease; embryo; enzyme linked immunosorbent assay; erythrocyte sedimentation rate; fatigue; female; fever; genetic stability; headache; hemagglutination inhibition test; hemagglutination test; human; human cell; iatrogenic disease; immunogenicity; immunological technique; influenza A (H2N2); influenza vaccination; male; memory T lymphocyte; microneutralization assay; monocyte; neutrophil count; normal human; periodontitis; peripheral blood mononuclear cell; phase 1 clinical trial; randomized controlled trial; real time polymerase chain reaction; RNA isolation; sore throat; virus isolation; virus replication; virus shedding; virus transmission; vomiting; adolescent; immunology; Influenza A virus (H2N2); Influenza, Human; young adult; Adolescent; Adult; Double-Blind Method; Female; Healthy Volunteers; Humans; Influenza A Virus, H2N2 Subtype; Influenza Vaccines; Influenza, Human; Male; Young Adult
Издатель
- Taylor and Francis Inc.
Тип документа
- journal article
Источник
- scopus
