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Grant Funds Typhoid Vaccine Patch Development

Salmonella Typhi bacteria

Salmonella Typhi bacteria responsible for typhoid fever (Public Health Library, CDC.gov)

24 Aug. 2023. A health research foundation grant is funding development of a vaccine protecting against typhoid fever, given in a patch from from a spring-loaded device. Vaxxas Inc. in Cambridge, Massachusetts and Hamilton, Australia is receiving a $3.7 million award from the Wellcome organization, a charitable health research and advocacy group in the U.K., and developing the typhoid vaccine patch with SK bioscience in Seongnam-si, South Korea.

Vaxxas develops a device that administers vaccines from a small, single-use patch made with microscale needles, about 0.25 mm in length, coated with a dry form of the vaccine. The needles, says Vaxxas, penetrate the very outer skin layers, enough to stimulate an immune response. The high-density micro-array patch or HD-MAP, is placed on the skin from a spring-loaded dispenser that also seals the patch before use. The dried vaccine applied to the microscale needles on the patch do not need refrigeration, enabling storage and transport in ambient temperatures, an advantage over conventional syringe-administered vaccines.

As reported in Science & Enterprise, Vaxxas is testing the HD-MAP device in clinical trials with vaccines for influenza and Covid-19, with results presented in June showing the Covid-19 vaccine patch is well-tolerated and induces an immune response. Results of a separate trial reported earlier this year shows the HD-MAP can be administered by patients themselves with results similar to administration by clinicians.

Parts of a pathogen to generate an immune response

In their collaboration, Vaxxas is testing a conjugate vaccine made by SK bioscience for typhoid fever formulated for HD-MAP administration. Typhoid fever, says World Health Organization, is an infection from Salmonella Typhi bacteria, spread through contaminated water and food, and often found in locations without adequate sanitation or safe drinking water. WHO says some 9 million people are affected by typhoid fever each year with symptoms including fever, nausea, abdominal pain, headache, and diarrhea that can become life-threatening.

WHO recommends conjugate vaccines to protect against typhoid fever infection since they can be given to children as young a six months and adults in some cases up to 65 years of age. Conjugate vaccines use one or more parts of a pathogen to generate a strong immune response. SK bioscience developed its SKYTphoid conjugate vaccine with International Vaccine Institute and is already approved for export, according to the company. In the collaboration with Vaxxas, the two companies are reformulating the SKYTphoid vaccine for use with the HD-MAP device.

The Wellcome organization is providing $3.67 million for the two-year initiative, covering preclinical studies of a typhoid fever vaccine delivered with an HD-MAP device, leading to an investigational new drug application, in effect a request to regulatory authorities to begin clinical trials. The funding also covers an early-stage clinical trial.

“To help protect more people at risk from deadly diseases like typhoid fever,” says Wellcome organization senior research manager Pierre Balard in a Vaxxas statement released through BusinessWire, “new vaccine innovations are needed to improve access and ensure equitable coverage.” Ballard adds, “With the potential to overcome some of the most enduring barriers to vaccine access in lower income countries, this product could be a vital addition to our global toolkit.”

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