Format

Send to

Choose Destination
See comment in PubMed Commons below
Vaccine. 2013 Jul 25;31(34):3435-41. doi: 10.1016/j.vaccine.2013.01.050. Epub 2013 Feb 8.

Influenza subunit vaccine coated microneedle patches elicit comparable immune responses to intramuscular injection in guinea pigs.

Author information

1
Novartis Vaccines and Diagnostics, 350 Massachusetts Avenue, Cambridge, MA-02139, United States. sushma.kommareddy@novartis.com

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.

KEYWORDS:

Influenza vaccine; Intradermal; Microneedles

PMID:
23398932
DOI:
10.1016/j.vaccine.2013.01.050
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Support Center