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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*.
Influenza Other Respir Viruses 2013; 7(6):1142-50IO

Abstract

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.

OBJECTIVES

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.

PATIENTS/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.

Authors+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23061976

Citation

Sheldon, Eric A., et al. "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*." Influenza and Other Respiratory Viruses, vol. 7, no. 6, 2013, pp. 1142-50.
Sheldon EA, Jeanfreau R, Sliman JA, et al. 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*. Influenza Other Respir Viruses. 2013;7(6):1142-50.
Sheldon, E. A., Jeanfreau, R., Sliman, J. A., Charenkavanich, S., Rousculp, M. D., Dubovsky, F., & Mallory, R. M. (2013). 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*. Influenza and Other Respiratory Viruses, 7(6), pp. 1142-50. doi:10.1111/irv.12027.
Sheldon EA, et al. 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*. Influenza Other Respir Viruses. 2013;7(6):1142-50. PubMed PMID: 23061976.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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*. AU - Sheldon,Eric A, AU - Jeanfreau,Robert, AU - Sliman,Joseph A, AU - Charenkavanich,Supoat, AU - Rousculp,Matthew D, AU - Dubovsky,Filip, AU - Mallory,Raburn M, Y1 - 2012/10/14/ PY - 2012/10/16/entrez PY - 2012/10/16/pubmed PY - 2014/6/19/medline KW - Immunogenicity KW - intranasal drug administration KW - live attenuated influenza vaccine KW - quadrivalent SP - 1142 EP - 50 JF - Influenza and other respiratory viruses JO - Influenza Other Respir Viruses VL - 7 IS - 6 N2 - 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. OBJECTIVES: 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. PATIENTS/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. SN - 1750-2659 UR - https://www.unboundmedicine.com/medline/citation/23061976/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__ L2 - https://doi.org/10.1111/irv.12027 DB - PRIME DP - Unbound Medicine ER -