Immunologic mechanisms of seasonal influenza vaccination administered by microneedle patch from a randomized phase I trial

Abstract

In a phase 1 randomized, single-center clinical trial, inactivated influenza virus vaccine delivered through dissolvable microneedle patches (MNPs) was found to be safe and immunogenic. Here, we compare the humoral and cellular immunologic responses in a subset of participants receiving influenza vaccination by MNP to the intramuscular (IM) route of administration. We collected serum, plasma, and peripheral blood mononuclear cells in 22 participants up to 180 days post-vaccination. Hemagglutination inhibition (HAI) titers and antibody avidity were similar after MNP and IM vaccination, even though MNP vaccination used a lower antigen dose. MNPs generated higher neuraminidase inhibition (NAI) titers for all three influenza virus vaccine strains tested and triggered a larger percentage of circulating T follicular helper cells (CD4 + CXCR5 + CXCR3 + ICOS + PD-1+) compared to the IM route. Our study indicates that inactivated influenza virus vaccination by MNP produces humoral and cellular immune response that are similar or greater than IM vaccination.

Role of drug delivery technologies in the success of COVID-19 vaccines: a perspective

“…In this context, it is important to highlight that the skin is a particularly immunogenically active organ. Indeed, Prausnitz and others have shown a number of times that intradermal vaccination leads to a much better immune response than the classical intramuscular vaccination [ 34 – 36 ]. The simple explanation for this is that the skin is the body’s first defense barrier against outside pathogens, so it is well equipped with an innate and an acquired immune mechanism to fight those exogenous intruders.…”

“…For example, using dissolvable microneedles will overcome risks of reuse and needle-stick injuries as they will dissolve in the skin leaving no sharps behind. In the longer term, it is not known if the microneedles can make a vaccine safer but they can certainly enable targeted vaccination in the skin with evidences of stronger immune responses, broader protection, and longevity of protection compared to intramuscular vaccination for instance [ 34 – 36 ].…”

Microneedles in Drug Delivery: Progress and Challenges

“…The therapeutic loads are encapsulated, stored, and protected in the scaffold and delivered into the targeted area after the skin insertion via a polymer erosion mechanism, without leaving any biohazardous waste. A successful application of dMNs in vaccine delivery, for instance, has been demonstrated [54]. Sucrose and fish gelatin-based MNs have been used for vaccine delivery.…”

Nanovaccine Delivery Approaches and Advanced Delivery Systems for the Prevention of Viral Infections: From Development to Clinical Application

“…Importantly, lower pain scores were reported by the participants in comparison with IM injection, and a general preference for TD vaccination was registered in this study. The authors also recently published an additional analysis of the results obtained in this study, particularly in terms of the mechanisms behind the immune response observed in the different study groups [306]. The results showed that hemagglutinin inhibition titres and antibody avidity were similar between TD and IM immunisation, despite the lower antigen dose in the MN array group.…”