Delivering fractional doses successfully

By Daphne Allen in Drug-Delivery Devices on November 03, 2017

An adapter for syringes can help ensure the safe and effective delivery of fractional inactivated poliovirus vaccine (fIPV), a study has shown.

At the 4th Skin Vaccination Summit, Dr. Ondrej Mach, Clinical Trials and Research Team Lead, Polio Department, World Health Organization (WHO), shared results of a two-phase study in Pakistan. The study shows that fIPV delivered using West Pharmaceutical Services’s ID Adapter with a staked needle syringe by Helm Medical GMBH provides a safe, effective option. The study results were recently published in the journal Vaccine.

Researchers from Aga Khan University led the study with funding from the WHO and support from the Centers for Disease Control and Prevention. Phase 1 assessed the usability and immune response of fIPV administration in children ages 6-12 months with two novel intradermal adapters, one of which was developed by West with a syringe from Helm Medical GMBH, West reports. Phase 2 considered the feasibility of conducting a door-to-door vaccination campaign to administer the fIPV to children under 5 years old. “The study results showed that the immune response achieved with one dose of fIPV administered via the Helm syringe with West’s ID Adapter was similar to that achieved by fIPV administered with conventional needle and syringe,” the company reports.

Administering fIPV using a syringe and an ID Adapter differs from typical approaches, but the technique isn’t new. “Traditionally, IPV is administered subcutaneously and required a full dose. A fractional dose of IPV uses only 20% of a full dose to get the same immune response,” Glen Zimmermann, West’s director of product management, tells PMP News. “As you can imagine, the savings are considerable, and a limited IPV supply can go further.”

“The ID Adapter is not a new method,” he continues. “Intradermal injection (i.e., the Mantoux technique) has been around since the early 1900s, but the challenge has been to accurately deliver the dose to the narrow space just below the skin surface. This made it technically difficult to administer relative to intramuscular or subcutaneous injection.”

Other studies have shown that a 20% fractional dose of intradermal IPV is just as effective as a full dose of intramuscular inactivated poliovirus vaccine (please see this study and this study, among others cited by West. Professionals can be trained to manage the technique, but a solution that requires minimal end-user training could make the lower-dose approach more feasible.

West’s ID Adapter consists of a sterile, single-use injection-molded part that snaps onto a 1mL 1/2 inch fixed-needle allergy syringe. The device guides the angle and limits the depth of needle insertion for an easier, more-consistent intradermal injection. It “guides the injection to the proper space, greatly improving the accuracy and deliver to the intradermal space,” Zimmermann explains.

The ID Adapter has been approved for use in the United States and EU for several years, he says, and its first commercial application was in 2016 with the WHO. 

“We are pleased that our ID Adapter performed so well in this critical research study that addresses a vital medical need,” said Karen A. Flynn, West’s senior vice president & chief commercial officer, in a news release. “West is proud to offer a solution that can help improve the reliability and performance of intradermal injections while also extending the limited supply of IPV.”

Use of the ID Adapter could expand. Zimmermann says that a “polio eradication initiative is aware of the ID Adapter, and the ID Adapter is part of an emergency preparedness program for use in other affected regions. [And] as more vaccines are formulated for ID injections, the number of ID Adapter uses will increase.”

For more information about West, visit www.westpharma.com

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amazing post!!