Immunogenicity of a quadrivalent Ann Arbor strain live attenuated influenza vaccine delivered using a blow-fill-seal device in adults: a randomized, active-controlled study*.
BACKGROUND
Influenza B strains from two distinct lineages (Yamagata and Victoria) have cocirculated over recent years. Current seasonal vaccines contain a single B lineage resulting in frequent mismatches between the vaccine strain and the circulating strain. An Ann Arbor strain quadrivalent live attenuated influenza vaccine (Q/LAIV) containing B strains from both lineages is being developed to address this issue.


OBJECTIVE
The goal of this study was to evaluate whether Q/LAIV administered intranasally as a single dose to a single nostril, using a blow-fill-seal (BFS) delivery system had a similar immunogenicity and safety profile compared with the licensed trivalent vaccine delivered using the Accuspray device.


METHODS
Adults aged 18-49 years were randomized to receive one intranasal dose of Q/LAIV delivered using a BFS device (Q/LAIV-BFS; n=1202) or one of two trivalent live attenuated influenza vaccines (T/LAIV) containing one of the corresponding B strains (total T/LAIV, n=598). Primary endpoints were the post-vaccination strain-specific serum hemagglutination inhibition antibody geometric mean titers for each strain. Secondary immunogenicity endpoints, safety, and acceptability of the BFS device were also assessed.


RESULTS
Q/LAIV was immunogenically non-inferior to T/LAIV for all four influenza strains. Secondary immunogenicity outcomes were consistent with the primary endpoint. Solicited symptoms and AEs were comparable in both groups. Subjects considered the BFS device to be acceptable.


CONCLUSIONS
Immune responses to vaccination with Ann Arbor strain Q/LAIV-BFS were non-inferior to those with T/LAIV. Q/LAIV may confer broader protection against seasonal influenza B by targeting both major influenza B lineages.
Rheumatology and Internal Medicine, Miami Research Associates, Miami, FL, USAInternal Medicine, Benchmark Research, Metairie, LA, USAVanda Pharmaceuticals, Inc., Washington, DC, USAi3Statprobe, Clarksburg, MD, USAComparative Effectiveness Research, GlaxoSmithKline, Research Triangle Park, NC, USAClinical Development, MedImmune, LLC, Gaithersburg, MD, USA.
Eric A
EA
Sheldon
Robert
R
Jeanfreau
Joseph A
JA
Sliman
Supoat
S
Charenkavanich
Matthew D
MD
Rousculp
Filip
F
Dubovsky
Raburn M
RM
Mallory
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D014611:Vaccination / Q000379:methods*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014739:Victoria; D055815:Young Adult
D000914:Antibodies, Viral; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated