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In a previous blog post, we discussed various devices and solutions used to overcome the challenges associated with Intradermal (ID) injections. These challenges are mainly associated with the Mantoux Technique, a manual ID injection using a needle and syringe. Lacking the skill needed for this technique creates a risk of injecting the product too deep or not sufficiently deep and rendering the dose either less or potentially ineffective. Previous posts also touched on some of the potential benefits associated with ID delivery when compared to the more familiar Subcutaneous or Intramuscular type injections. Two of the benefits we look at closer in this post are dose sparing and improved immune response. Additionally, we will see how these two benefits can be related.
In a study conducted by NanoPass Technologies Ltd. and Crucell Holland B.V. titled "Clinical Evaluation of a Novel Microneedle Device for Intradermal Delivery of an Influenza Vaccine: Are All Delivery Methods the Same?"1, it was concluded that the route of administration (ID vs. IM) as well as the delivery method (NanoPass MicronJet™ device vs. regular needle and syringe [Mantoux technique]), can result in a significantly higher antibody response. In addition, the data showed that using a fractionated dose by ID produced the same immune response to that of full dose IM. The below graph show antibody titers to the 3 strains included in the particular influenza A vaccine tested.
Immunogenicity (Fig. 1 and Table 2) was higher in the 3 g ID group using the MicronJet needle (Group C) compared to the ID groups using the conventional Mantoux needle (Groups A1, A2, and A3) and the IM group (Group B).
The observed difference in immunogenicity is possibly due to a higher success rate of delivering the vaccine to the dermis, where there is a richness in antigen presenting cells. Furthermore, the intradermal route via MicronJet microneedle may be viable for those that are low or even non-responders of the vaccine, as it shows a higher response in regards in to Geometric Mean Titer (GMT) fold increase that can possibly be correlated to a better immune response.
The full dose of 15 micrograms of the vaccine delivered via IM (Group B) shows no statistical difference when compared to 3 micrograms of the vaccine via MicronJet microneedle (Group C). This indicates that the vaccine administered with the MicronJet microneedle will reach the same immune response at a fraction of the dose (20%) of the full IM.
A second study, "Immune Response and Reactogenicity of Intradermal Administration Versus Subcutaneous Administration of Varicella-zoster Virus Vaccine: An Exploratory, Randomized, Partly Blinded Trial”2, focuses on the zoster vaccine, Zostavax®, that is commonly administered subcutaneously (SC) to prevent shingles. The graph depicts that participants who received full dose intradermal and 1/3 dose intradermal vaccination had significantly higher Geometric mean fold rise GMFR (p<0·0001) in varicella-zoster virus antibody titres post-vaccination than did those who received full subcutaneous dose. The lower intradermal zoster vaccine doses induced GMFRs comparable to that of full dose zoster vaccine given subcutaneously.
West now offers two unique devices designed to help deliver a reliable and consistent ID injection each and every time. The ID Adapter is a snap on guiding device ideal for mass vaccination in developing regions. West's recent partnership with NanoPass Technologies, Ltd provides a microneedle solution, MicronJet600™, which is ideal for a variety of immunotherapies and vaccinations. Both devices are suitable for a broad range of ages.
Contact West today to learn more about how we can help you overcome the ID delivery challenge.
MicronJet™ and MicronJet600™ are trademarks of NanoPass Technologies, Ltd.
Zostavax® is a registered trademark of Merck Sharp & Dohme Corp.
Vaccines have helped reduce the instance of infectious diseases around the globe, nearly eradicating past plagues, such as smallpox and polio. A very effective method of delivery is intradermal (ID) injection – now made easier with two novel products on the market.
Designed to help improve consistency and reliability of intradermal inject.
Microneedles have been around for the past two decades; however, recent advances in technology have enabled their manufacturing in a variety of different forms and at lower cost than previously possible. The technologies, ranging from hollow, solid, coated to dissolving, have captured the interest of many vaccine and drug manufacturers as an alternate form of delivery primarily due to the potential advantages associated with transdermal and intradermal delivery.<br />
Development of vaccines for COVID-19 and its variants continues to present challenges such as accelerated timelines. Since there is not the usual time available for selection, evaluation, and qualification of the package and delivery systems, risks must be mitigated at every phase. For vaccines packaged in prefilled syringes, use of an elastomer plunger laminated with FluroTec<sup>®</sup> film can help.
As scientists continue to gain a better understanding of the Corona virus, we are witness to a growing number of novel and repurposed therapeutics in development along with clinical trials designed to attack multiple aspects of the unique clinical pathologies. On the vaccine side, manufacturers are trying a multi-pronged approach to stimulate the immune system by using both traditional approaches (i.e., protein subunits, inactivated viruses, and virus-like particles) and novel platforms that are based on delivery of mRNA, DNA, or non-replicating viral vectors that can trigger the body to make the viral proteins themselves. The typical timelines, not counting the time it takes to demonstrate safety and efficacy of these vaccines, can range from months to years and even up to a decade to successfully design, manufacture and consistently produce high quality vaccines.
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