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Therapeutic vaccines

While much of the work on nasal vaccine delivery is currently focused on prophylactic vaccines, the access that the nasal route provides to the mucosal immune system also has relevance for therapeutic vaccines used to treat rather than prevent disease. Nasal immunotherapy for treatment of various cancers and Alzheimer are currently generating much interest.63,64 A particular focus is the use of therapeutic vaccines for the treatment of autoimmune diseases such as type I diabetes, atherosclerosis, multiple sclerosis, rheumatoid arthritis, lupus and Crohn's disease. These are caused by unchecked immune response to molecules, termed self-antigens, that are capable of inducing an immune response in a host but should not induce an immune response in a healthy individual that produces them, whereas undesirable response to innocuous environmental antigens gives rise to allergy. The autoimmune and inflammatory response is governed by regulatory T-cells (Tregs), with poor function or reduced numbers of Tregs being associated with autoimmune disease. Treatments for this family of diseases are often non-specific, or use immune suppressants that increase susceptibility to infection. Development of effective therapeutic vaccine would correct the inappropriate immune response through generation of tolerance to the self-antigen(s).65 Treg cells that express the forkhead box P3 transcription factor are known as FoxP3+T-cells, with dysfunction of this subset of Tregs being implicated in a range of chronic inflammatory disorders.66 It has long been known that oral delivery is effective in generating antigen tolerance, through deliberate introduction of the antigen to food.67 More recently it has been shown that a similar tolerance induction can be achieved via nasal delivery through activation of the DCs in the draining lymph nodes to enhance induction of FoxP3+T-cells.68 Examples of successful nasal delivery include immunization to suppress atherosclerosis69,70 and arthritis.71 The effect of adjuvant on tolerance is discussed in a later section.

This review has focused primarily on prophylactic vaccines but there is encouraging evidence that nasal delivery will have a role to play in the design of therapeutic vaccines for e.g. cancers Alzheimer and autoimmune diseases. The role of presentation is also important when designing pre-clinical studies – instillation of drops is relatively facile even in mice, while more advanced formulations require more careful consideration than those administered via pipette. The design of ex vivo, cell culture or tissue models that provide better prediction of response in humans is extremely desirable. A “one size fits all” approach is not appropriate for vaccine design where factors relating to target population, disease type and mode of infection, will all impact on both formulation and antigen optimization.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5287317/

If human trials are successful and, given the unprecedented need for drugs to combat COVID-19, this prophylactic immune modulation therapy could be rapidly manufactured at scale and be available for use within 18 months.

https://www.prnewswire.com/news-releases/research-on-preventative-nasal-spray-which-protects-against-covid-19-and-common-cold-published-in-leading-peer-reviewed-academic-journals-301195657.html

prophylactic vaccines

Codagenix, Serum Institute take nasal COVID-19 vaccine into clinic

Altimmune has a single-dose intranasal candidate in development. Altimmune is set to publish phase 1 data early next year. Vaxart is closing in on the delivery of clinical data on its oral candidate, and ImmunityBio is preparing to take its oral prospect into the clinic.

https://www.fiercepharma.com/drug-delivery/codagenix-serum-institute-take-nasal-covid-19-vaccine-into-clinic

Prophylactic spray could be used against Covid-19

https://www.irishtimes.com/business/health-pharma/open-orphan-company-successfully-completes-nasal-spray-study-1.4444629