Inhalable dry powder aerosol vaccines require no needle, no water, no reconstitution and no electricity or batteries for delivery, which makes them especially useful in developing countries. To facilitate aerosol delivery, our team invented the PuffHaler�, an �active� dry powder inhaler with only one moving part, a simple squeeze bulb with its pressure release valve. We also invented a special form of spray drying, Carbon Dioxide Assisted Nebulization with a Bubble Dryer (CAN-BD), that produces aerosol microparticles small enough (1-5 microns aerodynamic diameter) to be distributed throughout the moist respiratory tracts of humans and test animals in which immune responses are generated. A challenge study at the Johns Hopkins Bloomberg School of Public Health in Rhesus macaques showed that the monkeys were fully protected when exposed to wild-type Bilthoven strain measles virus 13 months after vaccination with Edmonston-Zagreb strain live-attenuated measles virus vaccine inhaled aerosol. This dry powder aerosol vaccine has also been administered to 40 human volunteers without any serious adverse events observed while following the patients 180 days after this Phase I safety clinical trial began in India. This development over the past 9 years by a team of 35 chemists, engineers, physicians, immunologists, public health specialists, students and post-docs has been made possible by a $20 million grant (FNIH Grant 1077) from the Foundation for the National Institutes of Health as part of the Grand Challenges in Global Health initiative created by the Bill and Melinda Gates Foundation.

Development of needle-free and water-free inhalable dry powder aerosol vaccines

248th National Meeting (2014)

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