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Development of Pediatric Dosage Preparation for CVD 103-HgR Live Oral Cholera Vaccine

R. Paul DuffinEmergent BioSolutions, Gaithersburg, Maryland

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Michael DelbuonoEmergent BioSolutions, Gaithersburg, Maryland

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Kylie NishiokaEmergent BioSolutions, Gaithersburg, Maryland

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Paul ShabramEmergent BioSolutions, Gaithersburg, Maryland

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Amish A. PatelEmergent BioSolutions, Gaithersburg, Maryland

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ABSTRACT.

PXVX0200 is an oral cholera vaccine that is approved for use by the U.S. Food and Drug Administration and European Medicines Agency under the tradename Vaxchora. The vaccine is supplied as two packets, one containing buffer component and the other the active component, that are mixed with water and ingested. The aim of this study was to develop vaccine preparation methods that are appropriate for administering PXVX0200 to children. Developing oral liquid medication for children has unique challenges, including administration volume and palatability. These challenges were addressed by preparing PXVX0200 in different volumes and testing the potency of the vaccine in the presence of sweeteners, flavorings, and food and drinks. Vaccine potency, defined as colony-forming units/dose, was used to determine the compatibility of PXVX0200 with different vaccine preparation methods. We found that the reconstitution volume can be reduced from 100 to 50 mL to accommodate children aged 2 to 6 years and to 10 mL for children aged 6 months to 2 years, as long as the buffer concentration is the same as for the approved (100 mL) dose. Sucrose or stevia sweeteners may also be added without affecting the vaccine potency. Reconstitution in juices or foods was challenging because of effervescence caused by bicarbonate in the buffer component. An alternate preparation method was developed for reconstitution in baby formula. Vaccine preparation methods to make PXVX0200 appropriate for pediatric administration will facilitate administration of the vaccine to improve compliance and protect children from cholera infection while traveling.

Author Notes

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

Authors’ addresses: R. Paul Duffin, Michael Delbuono, Kylie Nishioka, Paul Shabram, and Amish A. Patel, Emergent BioSolutions, Gaithersburg, MD, E-mails: duffinp@ebsi.com, michaeldelbuono@yahoo.com, nishiokak@ebsi.com, pshabram@ventanabiosciences.com, and patela3@ebsi.com.

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