title: Influenza subunit vaccine coated microneedle patches elicit comparable immune responses to intramuscular injection in guinea pigs.
abstract: Delivery of influenza vaccine using innovative approaches such as microneedles has been researched extensively in the past decade. In this study we present concentration followed by formulation and coating of monobulks from 2008/2009 seasonal vaccine on to 3M's solid microstructured transdermal system (sMTS) by a GMP-scalable process. The hemagglutinin (HA) in monobulks was concentrated by tangential flow filtration (TFF) to achieve HA concentrations as high as 20mg/ml. The stability of the coated antigens was evaluated by the functional assay, single radial immunodiffusion (SRID). The data generated show stability of the coated antigen upon storage at 4°C and room temperature in the presence of desiccant for at least 8 weeks. Freeze-thaw stability data indicate the stability of the coated antigen in stressed conditions. The vaccine coated microstructures were evaluated in vivo in a guinea pig model, and resulted in immune titers comparable to the traditional trivalent vaccine administered intramuscularly. The data presented indicate the potential use of the technology in delivery of influenza vaccine. This paper also addresses the key issues of stability of coated antigen, reproducibility and scalability of the processes used in preparation of influenza vaccine coated microneedle patches that are important in developing a successful product.
authors: Novartis Vaccines and Diagnostics, 350 Massachusetts Avenue, Cambridge, MA-02139, United States. sushma.kommareddy@novartis.com
authors: S
authors: S
authors: Kommareddy
authors: B C
authors: BC
authors: Baudner
authors: A
authors: A
authors: Bonificio
authors: S
authors: S
authors: Gallorini
authors: G
authors: G
authors: Palladino
authors: A S
authors: AS
authors: Determan
authors: D M
authors: DM
authors: Dohmeier
authors: K D
authors: KD
authors: Kroells
authors: J R
authors: JR
authors: Sternjohn
authors: M
authors: M
authors: Singh
authors: P R
authors: PR
authors: Dormitzer
authors: K J
authors: KJ
authors: Hansen
authors: D T
authors: DT
authors: O'Hagan
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D000956:Antigens, Viral / Q000008:administration & dosage / Q000276:immunology; D004355:Drug Stability; D005260:Female; D006168:Guinea Pigs; D006385:Hemagglutination Inhibition Tests; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000008:administration & dosage / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000276:immunology; D007273:Injections, Intramuscular; D051379:Mice; D008807:Mice, Inbred BALB C; D009976:Orthomyxoviridae Infections / Q000276:immunology* / Q000517:prevention & control; D015203:Reproducibility of Results; D057968:Transdermal Patch; D014611:Vaccination / Q000295:instrumentation / Q000379:methods; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D000956:Antigens, Viral; D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D022223:Vaccines, Subunit
keywords: Influenza vaccine; Intradermal; Microneedles