Improving the intradermal administration of the polio vaccine

The study results were presented at the Fourth Skin Vaccination Summit in May 2017 by Dr Ondrej Mach, Clinical Trials and Research Team Lead, Polio Department, World Health Organization (WHO), and recently published in the journal Vaccine.¹

The two-phase field campaign evaluated the feasibility of using fractional inactivated poliovirus vaccine (fIPV) in remote locations where polio outbreaks have persisted. The study demonstrated that fIPV delivered via West’s ID Adapter, used in conjunction with a staked needle syringe by Helm Medical GMBH, offers a safe, effective, dose-sparing option for drug delivery.

Karen A. Flynn, Senior VP & Chief Commercial Officer, at West, said: “We are pleased that our ID Adapter performed so well in this critical research study that addresses a vital medical need. 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.”

Polio (poliomyelitis) is a highly infectious disease that mainly affects children under five years of age. Caused by a virus, polio invades the nervous system and can cause partial to total paralysis in a matter of hours. There is no cure for polio; it can only be prevented through administration of the polio vaccine.²

Fortunately, a 20% fractional dose of intradermal IPV has been proven just as effective as a full dose of intramuscular inactivated poliovirus vaccine, while allowing significant dose sparing.^3–10

While intradermal administration has been proven to be a safe, effective method for delivering fractional doses of many vaccines, greater technical skill is required to deliver the dose. West’s ID Adapter addresses this problem.

Conducted in Pakistan, where polio outbreaks have persisted, this study sought to evaluate the use of fIPV in conjunction with two types of intradermal devices for outbreak response and routine immunisations of children.

The study was led by researchers from Aga Khan University with funding from the WHO and support from the Centers for Disease Control and Prevention (CDC). The study was comprised of two phases: 

• 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.
• phase 2 evaluated 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 data also demonstrated the safety and usability of intradermal devices in difficult field conditions and showed that fIPV can be used successfully for both primary immunisation and as an alternative to full-dose IPV.

References

1. AF Saleem et al., "Needle adapters for intradermal administration of fractional dose of inactivated poliovirus vaccine: Evaluation of immunogenicity and programmatic feasibility in Pakistan," Vaccine 35(24), 3209–3214, May 2017.
2. World Health Organization. Poliomyelitis Fact Sheet. April 2017. Retrieved from: http://www.who.int/mediacentre/factsheets/fs114/en/
3. A.J. Mohammed, S. AlAwaidy, S. Bawikar, "Fractional doses of inactivated poliovirus vaccine in Oman," N Engl J Med. 362, 2351–2359, 2010.
4. S. Nirmal et al., “Immune response of infants to fractional doses of intradermally administered inactivated poliovirus vaccine,” Vaccine 16, 928–931, 1998.
5. S. Resik, A. Tejeda, O. Mach, "Immune responses after fractional doses of inactivated poliovirus vaccine using newly developed intradermal jet injectors: a randomized controlled trial in Cuba," Vaccine 33, 307–313, 2015.
6. C.F. Estivariz, H. Jafari, R.W. Sutter, "Immunogenicity of supplemental doses of poliovirus vaccine for children aged 6–9 months in Moradabad, India: a community-based, randomised controlled trial," Lancet Infect Dis. 12, 128–135, 2012.
7. D. Soonawala, P. Verdijk, A.J. Wijmenga-Monsuur, "Intradermal fractional booster dose of inactivated poliomyelitis vaccine with a jet injector in healthy adults," Vaccine 31, 3688–3694, 2013.
8. K.S. Nelson et al., "Intradermal fractional dose inactivated polio vaccine: a review of the literature," Vaccine 30, 121–125, 2012.
9. S. Resik, A. Tejeda, P.M. Lago, "Randomized controlled clinical trial of fractional doses of inactivated poliovirus vaccine administered intradermally by needle-free device in Cuba," J Infect Dis. 201, 1344–1352, 2012.
10. S. Resik, A. Tejeda, R.W. Sutter, "Priming after a fractional dose of inactivated poliovirus vaccine," N Engl J Med. 368 416–424, 2013.