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| Past two years | Past Year | Past 30 Days | |
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Development of Pediatric Dosage Preparation for CVD 103-HgR Live Oral Cholera Vaccine
R. Paul Duffin
R. Paul Duffin
Emergent BioSolutions, Gaithersburg, Maryland
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Michael Delbuono
Michael Delbuono
Emergent BioSolutions, Gaithersburg, Maryland
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Kylie Nishioka
Kylie Nishioka
Emergent BioSolutions, Gaithersburg, Maryland
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Paul Shabram
Paul Shabram
Emergent BioSolutions, Gaithersburg, Maryland
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Amish A. Patel
Amish A. Patel
Emergent 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
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.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Ali M , Nelson AR , Lopez AL , Sack DA , 2015. Updated global burden of cholera in endemic countries. PLoS Negl Trop Dis 9: e0003832.
-
2.
Azman AS , Rudolph KE , Cummings DA , Lessler J , 2013. The incubation period of cholera: a systematic review. J Infect 66: 432–438.
-
3.
Barrett TJ , Cameron DN , 1998. Cholera. Methods Mol Med 15: 369–385.
-
4.
Azizi A , Kumar A , Diaz-Mitoma F , Mestecky J , 2010. Enhancing oral vaccine potency by targeting intestinal M cells. PLoS Pathog 6: e1001147.
-
5.
Davitt CJ , Lavelle EC , 2015. Delivery strategies to enhance oral vaccination against enteric infections. Adv Drug Deliv Rev 91: 52–69.
-
6.
European Medicines Agency : EMA/CHMP/QWP/805880/2012 Rev. 2—Guideline on pharmaceutical development of medicines for paediatric use.
-
7.
Levine MM , Chen WH , Kaper JB , Lock M , Danzig L , Gurwith M , 2017. PaxVax CVD 103-HgR single-dose live oral cholera vaccine. Expert Rev Vaccines 16: 197–213.
-
8.
Nagita A et al., 1996. Diurnal variation in intragastric pH in children with and without peptic ulcers. Pediatr Res 40: 528–532.
-
9.
Boyle JT , 2003. Acid secretion from birth to adulthood. J Pediatr Gastroenterol Nutr 37(Suppl 1): S12–S16.
-
10.
Baguley D , Lim E , Bevan A , Pallet A , Faust SN , 2012. Prescribing for children - taste and palatability affect adherence to antibiotics: a review. Arch Dis Child 97: 293–297.
-
11.
U.S. Food and Drug Administration, 2018. Additional Information about High-Intensity Sweeteners Permitted for Use in Food in the United States U.S. Food & Drug Administration, official website of the United States Government. Available at: https://www.fda.gov/food/food-additives-petitions/additional-information-about-high-intensity-sweeteners-permitted-use-food-united-states.
-
12.
Nalawade TM , Bhat K , Sogi SH , 2015. Bactericidal activity of propylene glycol, glycerine, polyethylene glycol 400, and polyethylene glycol 1000 against selected microorganisms. J Int Soc Prev Community Dent 5: 114–119.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 2082 | 1297 | 67 |
| Full Text Views | 136 | 15 | 0 |
| PDF Downloads | 90 | 15 | 0 |