NanoStat™ Mucosal Vaccines

The NanoBio NanoStat mucosal vaccine platform supports a variety of vaccines to include influenza, H5N1, hepatitis B, pneumonia, tuberculosis, small pox anthrax and other viral and bacterial diseases.

Mucosal vaccines offer unique advantages for many infectious diseases.  Literature indicates that infectious agents transmitted through mucosal surfaces may be better prevented through mucosal immunity.  It has also been shown that mucosal immunity is most effectively elicited by mucosal vaccines. 1, 2  Nanoemulsion vaccines stabilize the antigen, and because it is antimicrobial it obviates the need for other preservatives or refrigeration.  An additional benefit relates to ease of administration without risk of disease transmission due to accidental needle sticks, potentially allowing for vaccination by non-medical staff. 

We have shown that when either whole or a recombinant protein antigen is simply mixed with nanoemulsion and placed on the nanso pharynx, the nanoemulsion serves as a potent adjuvant, producing both mucosal immunity and systemic immune response.  This is accomplished without the need for additional immunostimulants through a process that involve the uptake of the nanoemulsion/antigen mixture by the dendritic cell.  This is due to the small size and high potential energy of the nanoemulsion droplet, and the efficiency by which the nanoemulsion is endocytosed by dendritic cells. (Figures 1 & 2)

Development and manufacturing process for the multiple indications supported by the platform technology are streamlined as one common nanoemulsion base formulation is appropriate for all NanoStat vaccines.  This platform nanoemulsion has an extremely favorable safety profile as it is comprised of GRAS components plus an approved detergent, at low concentration and is dosed in small volume.  Extensive safety studies demonstrate that NanoStat nanoemulsions have shown no toxicity or irritation in the upper respiratory tract. 

Fig. 1:  Nanoemulsion Particles Enhance The Immune Response

Fig. 2:  Nanoemulsion Particles are Rapidly Taken up by Dendritic Cells

Study confirms the significantly increased uptake of florescenced PA protein (antigen) in Jawsll cells incubated in the presence of 0.001% nanoemulsion in an Enzyme-Linked ImmunoSorbent Assay (ELISA) using anti-PA mouse serum

1. Belyakov, I.M., Z. Hel, B. Kelsall, V.A. Kuzetsov, J. D. Ahlers, J. Nacsa, D. I. Watkins, T. M. Allen, A. sette, J. Altman, R. Woodward, P.d. Markham, J. D. Clements, G. Franchini, W. Strober, and J. A. Berzofsky. 2001.  Mucosal AIDS vaccine reduces disease viral load in gut reservoir and blood after mucosal infection of macaques. Nat. Med. 7:1320-1326.

2. Lehner, T., L. Bergmeier, Y. Wang, L. Tao, and E. Mitchell. 1999.  A rational basis for mucosal vaccination against HIV infection.  Immunol. rev. 170:183-196.