Vaccines injected intra-muscularly (IM) or subcutaneously generate systemic immunity but do not create the strong mucosal immunity desirable for protection against pathogens that enter the body via mucosal surfaces (such as influenza, RSV and SARS-Cov-2).
Challenging pathogens at their portal of entry will likely increase the efficacy of existing vaccines, reduce disease transmission, and may protect against future pathogen variants.
Intra-nasal vaccinations have typically failed to generate strong and reliable mucosal or systemic responses.
The phase 1 clinical study of AstraZeneca’s COVID-19 vaccine demonstrated it was successful when administered IM but failed when administered intranasally (1,2). University of Oxford’s Prof Alexander Douglas led the team and, in describing the results, said “We urgently need more research to develop vaccines which can block transmission of respiratory pandemic viruses using delivery routes which are safe and practical at large scale” (2).
muPharma has created a non-invasive, ultrasound mediated, hand-held, vaccine delivery device for application to the lip mucosa which in three independent studies generated mucosal and systemic immunity.
A Peter Doherty Institute for Infection and Immunity study, using a Live Attenuated Influenza Virus vaccine delivered to the lip mucosa by the muPharma device in a mouse model of influenza, demonstrated mucosal and systemic cellular immunity against an influenza virus. Importantly, protective levels of mucosal cellular immunity was generated in the upper respiratory tract. Another study performed at the Australian National University demonstrated in a live mouse model generation of mucosal cellular immunity in the gut (in addition to systemic cellular immunity) using a HIV vector virus vaccine delivered to the lip mucosa by the muPharma device. Duke University has demonstrated in live mice models that muPharma device delivery of a vaccine to the lip mucosa elicited levels of IgG and IgA in the vagina and levels of IgG in the spleen far in excess of that created by the intranasal and sublingual route.
muPharma’s delivery system will be discussed, and its safety and pre-clinical results presented.
muPharma’s delivery method addresses Prof Douglas’s challenge and raises the possibility that this approach could have clinical utility.
(1) Madhavan M et al. Tolerability and immunogenicity of an intranasally-administered adenovirus-vectored COVID-19 vaccine: an open label partially randomised ascending dose phase 1 study. eBioMedicine 85, 104298 (2022).
(2) Carvalho T. Intranasal COVID-19 vaccine fails to induce mucosal immunity. Nature Medicine 28, 2439-2440 (2022)