Статья

The Effect of Preexisting Immunity on Virus Detection and Immune Responses in a Phase II, Randomized Trial of a Russian-Backbone, Live, Attenuated Influenza Vaccine in Bangladeshi Children

E. Brickley, P. Wright, A. Khalenkov, K. Neuzil, J. Ortiz, L. Rudenko, M. Levine, J. Katz, W. Brooks,
2021

Background: In a 2012 Phase II clinical trial, 300 Bangladeshi children aged 24 to 59 months with no prior influenza vaccine exposure were randomized to receive a single intranasally-administered dose of either trivalent, Russian-backbone, live, attenuated influenza vaccine (LAIV) or placebo. Protocol-defined analyses, presented in the companion manuscript, demonstrate decreased viral detection and immunogenicity for A/H1N1pdm09, relative to the A/H3N2 and B strains. This post hoc analysis of the trial data aims to investigate the LAIV strain differences by testing the hypothesis that preexisting humoral and mucosal immunity may influence viral recovery and immune responses after LAIV receipt. Methods: We used logistic regressions to evaluate the relations between markers of preexisting immunity (ie, hemagglutination inhibition [HAI], microneutralization, and immunoglobulin G and immunoglobulin A (both serum and mucosal antibodies) and LAIV viral recovery in the week post-vaccination. We then tested for potential effect modification by baseline HAI titers (ie,

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  • 1. Version of Record от 2021-04-27

Метаданные

Об авторах
  • E. Brickley
    Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, United Kingdom
  • P. Wright
    Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, Germany
  • A. Khalenkov
    Department of Pediatrics, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756, United States
  • K. Neuzil
    Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, United States
  • J. Ortiz
    Department of Virology, Institute of Experimental Medicine, Saint Petersburg, Russian Federation
  • L. Rudenko
    Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, United States
  • M. Levine
    Department of International Health, Johns Hopkins University, Baltimore, MD, United States
  • J. Katz
  • W. Brooks
Название журнала
  • Clinical Infectious Diseases
Том
  • 69
Выпуск
  • 5
Страницы
  • 786-794
Ключевые слова
  • immunoglobulin A; immunoglobulin G; influenza vaccine; placebo; immunoglobulin A; immunoglobulin G; influenza vaccine; live vaccine; virus antibody; Article; Bangladeshi; child; controlled study; cross-sectional study; evaluation study; human; humoral immunity; immune response; logistic regression analysis; major clinical study; mucosal immunity; phase 2 clinical trial; post hoc analysis; priority journal; randomized controlled trial; Russian Federation; virus detection; virus shedding; virus strain; Bangladesh; blood; clinical trial; female; hemagglutination inhibition test; immunology; influenza; Influenza A virus (H3N2); intranasal drug administration; male; preschool child; vaccination; Administration, Intranasal; Antibodies, Viral; Bangladesh; Child, Preschool; Cross-Sectional Studies; Female; Hemagglutination Inhibition Tests; Humans; Immunoglobulin A; Immunoglobulin G; Influenza A Virus, H3N2 Subtype; Influenza Vaccines; Influenza, Human; Male; Vaccination; Vaccines, Attenuated; Virus Shedding
Издатель
  • Oxford University Press
Тип документа
  • journal article
Тип лицензии Creative Commons
  • CC
Правовой статус документа
  • Свободная лицензия
Источник
  • scopus