Vaccine patch
Biotech company Vaxxas, commercializing a new vaccination technique, has announced the completion of the first phase of a clinical trial proving the broad immunological potential of a new high-density microarray patch (HD-MAP). Using the flu vaccine, the researchers demonstrated a significantly more pronounced immune response after administration with HD-MAP compared to standard vaccination with a syringe.
A randomized, partially double-blind, placebo-controlled trial consisting of two stages was conducted in one clinical center in Australia. 210 volunteers participated in it. The main objective was to evaluate the safety and tolerability of the monovalent vaccine A/Singapore/GP1908/2015 H1N1 (A/Sing) injected into the body using HD-MAP and the standard intramuscular injection of the quadrivalent influenza vaccine (QIV) containing approximately the same amount of viral hemagglutinin protein as A/Sing. The immune response was assessed after applying HD-MAP to the forearm in 4 different doses of A/Sing compared with intramuscular administration of QIV with standard 15 micrograms of hemagglutinin. In addition, the researchers analyzed the further state of the immune response using additional tests, as well as the nature of the local skin response using puncture biopsy of HD-MAP application sites. Local skin reactions, local mucosal immunity, serological and cellular immune responses were evaluated before and after vaccination.
When using HD-MAP, a dose of 2.5 micrograms (1/6 of the standard dose) induced an immune response comparable to that after a standard dose of 15 micrograms administered intramuscularly. In a pandemic, lower doses may allow a much larger number of patients to be vaccinated with HD-MAP than with conventional intramuscular injections.
At higher doses (10 and 15 micrograms), HD-MAP leads to the rapid formation of very high antibody titers, faster and higher than 15 micrograms of the vaccine administered intramuscularly. The U.S. Centers for Disease Control and Prevention estimates that 500,000 flu deaths have occurred worldwide every year since 2010. The faster immune response achieved with HD-MAP will help provide protection against infection for days rather than weeks, and this is an important public health benefit in both seasonal influenza and pandemic. In addition, a higher overall immune response provides the potential to protect against diseases, which can cover a prolonged flu season.
According to an article published in PLoS Medicine, the HD-MAP vaccine remained effective when stored at temperatures up to 40°C for at least 12 months. This stability makes it possible to easily distribute the vaccine without the cost of storage in special conditions. In addition, the company is currently conducting a clinical study, which examines the possibility of self-use of HD-MAP without the participation of medical personnel. This would help with annual seasonal vaccination against influenza and other viruses to avoid the need to collect the population in medical institutions.
The HD-MAP from Vaxxas is easily made by injection molding, it is a 10x10 mm patch with more than 3000 microneedles exposed to gamma radiation before aseptic dry application of the vaccine to the tips of the HD-MAP. All elements of the device design, as well as its coatings and quality control were designed so that small modular aseptic lines could produce millions of products per week.
Article by A.H.Forster et al. Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial published in the journal PLOS Medicine.
Aminat Adzhieva, portal "Eternal Youth" http://vechnayamolodost.ru based on EurekAlert: Novel high-density microarray patch (HD-MAP) can deliver vaccines directly to the skin.