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Home Administration of CVD 103-HgR: A Live Attenuated Oral Cholera Vaccine

ABSTRACT

Vaccination is a well-established means for prevention and spread of disease in people traveling abroad. Although vaccines to diseases such as cholera are recommended by world health agencies, they are seldom required even when traveling to endemic regions. Consequences of noncompliance can affect traveler’s health and spread diseases to new regions, as occurred in Haiti in 2010 when United Nations peacekeepers from Nepal, where a cholera outbreak was underway, introduced the disease to the region. Steps to increase vaccine recommendation compliance should therefore be an integral part of vaccine development. PXVX0200 contains Center for Vaccine Development 103-HgR live, attenuated recombinant Vibrio cholerae vaccine strain, and is indicated for single-dose immunization against the bacteria that causes cholera. It is supplied as one buffer and one active component packet to be mixed into water and ingested. Administration instructions are designed to be “user friendly” with flexibility for self-administration, thus promoting compliance. Studies to support self-administration were conducted to cover stability of the vaccine outside of normal storage conditions, potency in case of misadministration, and disposal procedures to minimize environmental impact. The principal findings showed that the stability of vaccine was maintained under conditions allowing for transport times and temperature conditions as well as when misadministration errors were made. Finally, the vaccine was effectively neutralized with hot water and soap to prevent bacterial environmental contamination in the event of an accidental spill. The conclusion is that PXVX0200 oral vaccine is stable, easy to formulate and dispose of, and is amenable to self-administration.

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Author Notes

Address correspondence to Ryan Paul Duffin, Emergent BioSolutions, 400 Professional Dr., Suite 400 Gaithersburg, MD 20879. E-mail: duffinp@ebsi.com

Authors’ addresses: R. Paul Duffin, Michael Delbuono, and Amish A. Patel, Product Development, Emergent BioSolutions Inc, San Diego, CA, E-mails: duffinp@ebsi.com, michaeldelbuono@yahoo.com, and patela3@ebsi.com. Lawrence Chew, Analytical and Formulation Development, Emergent BioSolutions Inc, San Diego, CA, E-mail: chewl@ebsi.com. James Johnstone, Fermentation, Emergent BioSolutions Inc, San Diego, CA, E-mail: johnstonj@ebsi.com. Volker Niedan, Quality Control, Emergent BioSolutions Inc, San Diego, CA, E-mail: niedanv@ebsi.com. Pascal Schwarz, Manufacturing Operations, Emergent BioSolutions Inc, San Diego, CA, E-mail: schwarzp@ebsi.com. Paul Shabram, Technical Operations, Emergent BioSolutions Inc, San Diego, CA, E-mail: shabramp@ebsi.com.

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