Needleless vaccine patch offers pain-free way to protect against disease

Imagine being able to vaccinate yourself against disease at home, by yourself, without doctor’s offices— or needles. Then imagine using that same technology to vaccinate hundreds of people in third world countries to avoid epidemic situations. Thanks to one woman’s invention, this may soon be a reality.

Kasia Sawicka, 34, of Long Island, New York, has invented a needleless vaccination patch that has been successfully tested and used to combat the flu, whooping cough, anthrax and other antigens. The patch, called the ImmunoMatrix, is a non-invasive device that uses nanofibers to hold and effectively deliver a vaccine through the skin.

Sawicka’s journey to her invention started when she was an undergraduate at Stony Brook University in New York. She is a triple graduate of the university; in five years, she earned her undergraduate degree in engineering and chemistry and her master’s degree in chemistry, researching material science and engineering. In 2014, she completed her doctorate in biomedical engineering, and went on to work on clinical studies for burn treatments. Sawicka was recently offered a faculty position at her alma mater.

The benefits of needle-free delivery
Unlike traditional vaccine delivery systems, the proteins in the ImmunoMatrix nanofibers are very stable and can be kept at room temperature for 10 weeks or longer.

“The protein is a 3-D structure with the ability to fold and unfold,” Sawicka told FoxNews.com.  “It’s just like riding a very crowded elevator— you can’t really make any movement. We think by throwing the protein inside the very tight structure of the nanofibers, we’re preventing them from being able to do as they please and begin to denature.”

In fact, when the team did stability studies for the patch, they ran out of time points because they didn’t think the solution would be stable longer than 20 weeks, refrigerated.

Unlike a liquid vaccine formulation, which requires a glass vial, syringes, hypodermic needles, trained medical personnel, and biohazardous waste disposal, the patch can be self-administered with less waste— which makes it cost effective.

Additionally, the dose required for a patch is just 10 percent of that of a liquid vaccine injected into the muscle. The patch allows for delivery of a vaccine directly to the dermal-epidermal junction where there body’s most immunoresposive cells live, which is much more efficient than shots where the vaccine is delivered more superficially, Sawicka’s advisor, Sanford Simon, a professor of biochemistry and pathology at Stony Brook told FoxNews.com

The ability to address epidemic conditions is a potential application Sawicka is particularly excited about.

“Logistically speaking, if you think of a rapidly spreading pandemic, having the ability to vaccinate a large number of people is really the only way we know to date how to deal with it. If you need to train  emergency personnel, that presents a problem. What if we had a way to vaccinate people by just telling them to stick on a Band-Aid?” Sawicka said.

“Because the payload can be delivered to areas where it’s needed rapidly— no special handling required— then applied to the skin by someone whose sophistication is limited to that of applying a Band-Aid… it becomes possible to address these major challenges that have long bedeviled the health care profession in delivering vaccines to underserved areas,” Simon said.

The ImmunoMatrix has been tested on animals and on human skin samples.

Encasing vaccines for delivery
As an undergraduate, Sawicka was one of the first people to throw a protein enzyme in the electro-spinning process, which uses high electric fields to elongate polymer solutions to create nanofibers. The protein, which in this case is a vaccine, becomes encased in the nanofibers for eventual delivery into the skin.

Most passive delivery patches, such as the nicotine and birth control patches, are limited to substances that are less than 500 daltons in molecular weight. It was believed that anything larger than that would require mechanically disrupting the skin, through microneedles or another means, to penetrate the skin. Sawicka’s patch delivered substances that were approximately 300 times larger than 500 daltons, without any mechanical disruption.

Plus, unlike other patches, which are thin films that have only one surface of interaction with the skin, the ImmunoMatrix is highly porous and has the capacity to interact with skin on multiple layers.

“Having these highly porous 3-D structures that are composed of nanofibers that are approximately 1,000 times the width of a hair produces a huge surface area of reactivity between the skin and patch, and allows for more of an interaction,” Sawicka said.

Potential applications and future development
Sawicka started her own company to pursue applications for the patch and their first research focus is allergy treatment.  Currently, the only effective treatment is immunotherapy, which tricks the immune system into thinking whatever you’re allergic to is normal. Patients receive approximately 40 injections a year of small doses of the allergen and eventually become tolerant.

“What we’re hoping, what if instead of all those trips, you only had to go for a follow-up and in between apply a patch to wear 24 hours and eventually you would become de-sensitive and no longer have to spend money to treat symptoms,” she said.

Sawicka first started testing enzymes 44,000 daltons in molecular weight, then moved to larger and larger enzymes, eventually getting to encapsulating an antibody at 160,000 daltons. Antibodies are a focus of cancer treatment research, with scientists trying to identify molecular mechanisms that could prevent cancer from developing or spreading by adapting itself to the immune system.

The ImmunoMatrix technology has the potential to be used as a therapy for cancer, by mobilizing the immune system to recognize cancer cells as foreign bodies and attack. Sawicka’s strategy is focused on the delivery of specific proteins that attach to tumors. The tumors are then “flagged” with the antigen proteins and the body then responds by attacking the cancer cells.

Sawicka also hopes to look at using the patch for drug delivery for other therapeutics and to deliver diagnostic antibodies.

“This really is basically a platform device that I hope to be able to eventually explore all these different applications,” she said.

Getting the ImmunoMatrix into consumer use is approximately 10 years away, Sawicka estimated. First it must go through further research against a variety of vaccines. Studies will need to be done to ensure Sawicka’s pilot plan can translate into commercial-scale production. Plus, it will need to get approval from the Food and Drug Administration (FDA).

“These are all steps that will be required to translate the scientific findings into a commercially viable product,” Simon said. “This is a challenge though not only for Kasia, but also in general in the U.S. for developing new vaccines.”

However, because the patch doesn’t face problems such as stability of product, delivery apparatus and technology and education of users, Simon believes the process may be simplified.

“Kasia’s strategy is one that may help to get over the hump that has been classically bedeviling biomedical people in the U.S. to move something from the bench to the field without quite so many hurdles,” he said.

“The real-world [vaccine] application of this could potentially really have an impact, then I start daydreaming about other possibilities and if you can somehow add to the treatment of cancer or any other disease, adapting your technology in immunotherapies,” Sawicka said. “The door is only cracked open now, but it’s one I hope to run through eventually.”

The ImmunoMatrix patch was recently recognized as one of Popular Science magazine’s 2015 Invention Award winners and in November, Sawicka won first prize in the graduate division of the national Collegiate Inventors Competition. Now, she is one of ten finalists in the OneStart competition, the world’s largest life sciences and health care start up accelerator program. The winner, who will be chosen on May 21, will receive $150,000 in non-dilutive funds and free lab space and extensive mentoring.

“I feel like ever since the [Collegiate Inventor’s Competition] happened, everything has been, ‘the craziest thing just happened.’ I don’t even know where the baseline is,” Sawicka said.