NanoPass Phase III Polio Vaccine

NanoPass Technologies is collaborating with the US Center of Disease Control and prevention (CDC) in conducting a large phase 3 trial of polio vaccine in infants in South East Asia.

The study is a phase 3, open-label, randomized clinical trial comparing immune response after receiving one of five different combinations of polio vaccines delivered as oral drops or as injections into the muscle or the skin. Two of the vaccine regimens include a low (20%) dose

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vaccine delivered intradermally using the MicronJet device. The study is currently enrolling infants 6 weeks of age and aims to enroll over 1,200 participants.

In the pre-vaccine era, poliomyelitis was the leading cause of permanent disability. Two polio vaccines are used throughout the world to combat poliomyelitis (or polio); injected inactivated poliovirus (IPV) and live attenuated oral vaccine. IPV administration is needed globally to achieve polio eradication, but it is currently unaffordable for most of the developing world. Intradermal delivery may dramatically reduce the dose required for vaccination by several folds, thereby reducing the cost and increasing the affordability, of polio vaccines.

The MicronJet600 device is the shortest microneedle device presently registered with FDA, and since it is about half a millimeter long it is applicable for infants as well as adults.

NanoPass is involved in another Polio study in 231 HIV positive adults. The study is sponsored by the Eastern Virginia Medical School and aims to determine whether a lower dose of inactivated polio vaccine (IPV) injected ID can work equally well or better than the standard dose injected into the muscle. The study is enrolling participants infected with HIV because they are known to respond less well to vaccines than other groups.

NanoPass has also supported a pandemic flu phase I study sponsored by IDRI and Medicago, which investigated multiple strategies including intradermal delivery to improve immune responses and reduce doses for vaccination for the H5 pandemic flu vaccine.

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