title: Correlates of immune protection induced by live, attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine.
abstract: The authors conducted a 2-year, multicenter, double-blind, placebo-controlled efficacy field trial of live, attenuated, cold-adapted, trivalent influenza vaccine administered by nasal spray to children 15-71 months old. Overall, vaccine was 92% efficacious at preventing culture-confirmed infection by influenza A/H3N2 and influenza B. Because influenza A/H1N1 did not cause disease during the years in which this study was conducted, the authors sought to determine vaccine efficacy and correlates of immune protection against experimental challenge with 107 TCID50 of attenuated H1N1 (vaccine strain) by intranasal spray. Prechallenge assessments included serum hemaglutination-inhibiting (HAI) antibody and nasal wash IgA antibody to H1N1. Vaccine was 83% efficacious (95% confidence interval, 60%-93%) at preventing shedding of H1N1 virus after challenge. Any serum HAI antibody or any nasal wash IgA antibody was correlated with significant protection from H1N1 infection as indicated by vaccine-virus shedding, and high efficacy against H1N1 challenge was demonstrated.
authors.affiliation: Department of Medicine, Saint Louis University, St. Louis, MO 63110, USA. belsherb@slu.edu
authors.forename: R B
authors.initials: RB
authors.lastname: Belshe
authors.forename: W C
authors.initials: WC
authors.lastname: Gruber
authors.forename: P M
authors.initials: PM
authors.lastname: Mendelman
authors.forename: H B
authors.initials: HB
authors.lastname: Mehta
authors.forename: K
authors.initials: K
authors.lastname: Mahmood
authors.forename: K
authors.initials: K
authors.lastname: Reisinger
authors.forename: J
authors.initials: J
authors.lastname: Treanor
authors.forename: K
authors.initials: K
authors.lastname: Zangwill
authors.forename: F G
authors.initials: FG
authors.lastname: Hayden
authors.forename: D I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: K
authors.initials: K
authors.lastname: Kotloff
authors.forename: J
authors.initials: J
authors.lastname: King
authors.forename: P A
authors.initials: PA
authors.lastname: Piedra
authors.forename: S L
authors.initials: SL
authors.lastname: Block
authors.forename: L
authors.initials: L
authors.lastname: Yan
authors.forename: M
authors.initials: M
authors.lastname: Wolff
mesh_terms: D000281:Administration, Intranasal; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D003080:Cold Temperature; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D009980:Influenza A virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D008253:Macaca mulatta; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated