Development of Pediatric Dosage Preparation for CVD 103-HgR Live Oral Cholera Vaccine
Insights
New methods simplify oral cholera vaccine (PXVX0200) preparation for children. Reduced volumes and safe additives ensure vaccine potency, improving pediatric cholera protection during travel.
Area of Science:
- Vaccinology
- Pediatric Infectious Diseases
- Pharmaceutical Sciences
Background:
- PXVX0200 (Vaxchora) is an FDA-approved oral cholera vaccine.
- Pediatric administration presents challenges in volume and palatability for liquid medications.
Purpose of the Study:
- To develop and validate pediatric-friendly preparation methods for PXVX0200.
- To assess vaccine compatibility with various diluents, sweeteners, and food matrices.
Main Methods:
- Vaccine potency (CFU/dose) was measured after reconstitution in varied volumes (10-100 mL).
- Compatibility testing included sweeteners (sucrose, stevia), flavorings, and common foods/drinks.
- Alternative preparation methods were explored for challenging matrices like baby formula.
Main Results:
- Reconstitution volumes were successfully reduced to 50 mL (ages 2-6) and 10 mL (ages 6 months-2 years) maintaining buffer concentration.
- Sucrose and stevia did not impact vaccine potency.
- Effervescence issues arose with bicarbonate buffer in certain foods/juices; an alternative method for baby formula was developed.
Conclusions:
- Modified preparation methods enhance PXVX0200 suitability for pediatric administration.
- Optimized preparation can improve vaccine compliance and pediatric cholera prevention, especially for travelers.
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.
More Related Videos
Related Concept Videos
01:19One-Compartment Open Model for IV Bolus Administration: General Considerations
The drug's presence in the body is defined by an equation representing the difference between the rates of drug entry and exit. Key parameters—elimination rate constant,...
00:56One-Compartment Open Model for IV Bolus Administration: Estimation of Clearance
In the one-compartment open model for intravenous (IV) bolus administration, clearance is estimated by dividing the elimination rate by the plasma drug concentration. This equation leverages the elimination rate constant and the apparent...
01:01Dosage Regimen: Fixed Dose
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
01:18Two-Compartment Open Model: IV Bolus Administration
The disparity between drug input and the sum of drug transfer rates between...
01:25Routes of Drug Administration: Parenteral
The intravenous route (IV) of drug administration can be further categorized into two types. The bolus injection administers the entire dose rapidly, while an intravenous infusion slowly delivers smaller doses steadily.
The IV route is often...
01:09One-Compartment Open Model for IV Bolus Administration: Estimation of Elimination Rate Constant, Half-Life and Volume of Distribution