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Статья
Immunogenicity and Viral Shedding of Russian-Backbone, Seasonal, Trivalent, Live, Attenuated Influenza Vaccine in a Phase II, Randomized, Placebo-Controlled Trial among Preschool-Aged Children in Urban Bangladesh
2021
Background: We evaluated a Russian-backbone, live, attenuated influenza vaccine (LAIV) for immunogenicity and viral shedding in a randomized, placebo-controlled trial among Bangladeshi children. Methods: Healthy children received a single, intranasal dose of LAIV containing the 2011-2012 recommended formulation or placebo. Nasopharyngeal wash (NPW) specimens were collected on days 0, 2, 4, and 7. Reverse transcription polymerase chain reactions and sequencing identified the influenza virus (vaccine or wild-type). On days 0 and 21, blood specimens were collected to assess immunogenicity using hemagglutination inhibition, microneutralization, and immunoglobulin A (IgA) and G enzyme-linked immunosorbent assays (ELISAs); NPW specimens were also collected to assess mucosal immunogenicity using kinetic IgA ELISA. Results: We enrolled 300 children aged 24 through 59 months in the immunogenicity and viral shedding analyses. Among children receiving LAIV, 45% and 67% shed A/H3N2 and B vaccine strains, respectively. No child shed A/H1N1 vaccine strain. There were significantly higher day 21 geometric mean titers (GMTs) for the LAIV, as compared to the placebo groups, in all immunoassays for A/H3N2 and B (log10 titer P <. 0001; GMT Ratio >2.0). Among immunoassays for A/H1N1, only the mucosal IgA GMT was significantly higher than placebo at day 21 (log10 titer P =. 0465). Conclusions: Children vaccinated with LAIV had serum and mucosal antibody responses to A/H3N2 and B, but only a mucosal IgA response to A/H1N1. Many children shed A/H3N2 and B vaccine strains, but none shed A/H1N1. More research is needed to determine the reason for decreased LAIV A/H1N1 immunogenicity and virus shedding. Clinical Trials Registration: NCT01625689. © 2018 The Author(s) 2018.
Цитирование
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Версии
- 1. Version of Record от 2021-04-27
Метаданные
Название журнала
- Clinical Infectious Diseases
Том
- 69
Выпуск
- 5
Страницы
- 777-785
Ключевые слова
- immunoglobulin A; immunoglobulin G; influenza vaccine; placebo; triple vaccine; immunoglobulin A; influenza vaccine; live vaccine; virus antibody; antibody response; Article; child; clinical evaluation; comparative study; controlled study; double blind procedure; enzyme linked immunosorbent assay; hemagglutination inhibition; human; immunoassay; Influenza A virus (H3N2); influenza B; Influenza virus; major clinical study; phase 2 clinical trial; priority journal; randomized controlled trial; reverse transcription polymerase chain reaction; urban area; vaccine immunogenicity; virus neutralization; virus shedding; Bangladesh; clinical trial; female; immunology; influenza; Influenza A virus (H1N1); intranasal drug administration; male; nasopharynx; preschool child; urban population; virology; Administration, Intranasal; Antibodies, Viral; Bangladesh; Child, Preschool; Double-Blind Method; Female; Humans; Immunogenicity, Vaccine; Immunoglobulin A; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H3N2 Subtype; Influenza Vaccines; Influenza, Human; Male; Nasopharynx; Urban Population; Vaccines, Attenuated; Virus Shedding
Издатель
- Oxford University Press
Тип документа
- journal article
Тип лицензии Creative Commons
- CC
Правовой статус документа
- Свободная лицензия
Источник
- scopus
