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.
Highlights
Each year, seasonal influenza epidemics cause 3–5 million severe cases and 290,000 to 650,000 deaths globally[1]
Detailed immunologic analyses were performed on the group receiving 2014–2015 inactivated influenza virus vaccine (IIV) by microneedle patches (MNPs) (n = 11) versus IM route (n = 11), both delivered by a healthcare worker (Supplementary Fig. 1)
We found that Hemagglutination inhibition (HAI) responses to MNP and IM immunization were similar at 1 and 6 months after vaccination, and that HAI responses were higher at 1 month than at 6 months (Fig. 1, Supplementary Table 1)
Summary
Seasonal influenza epidemics cause 3–5 million severe cases and 290,000 to 650,000 deaths globally[1]. A better understanding of the immunologic mechanisms of influenza virus vaccines[3] is needed to overcome their limited effectiveness (10–60%)[4]. Delivery to the skin has been effective for many vaccines; most notably, the use of scarification for smallpox vaccine resulted in the worldwide eradication of this highly virulent disease. In addition to the Bacille Calmette-Guérin vaccination against tuberculosis[9], the intradermal route is approved for the delivery of seasonal influenza virus vaccine, which allowed for antigen sparing[10,11] and improvement of immunogenicity when equivalent doses of antigens have been compared (15 μg of HA per strain) between the intradermal and intramuscular (IM) routes[12]. To date, the use of skin delivery systems has been hampered by the lack of appropriate vaccine delivery systems combining reliability, safety, and simplicity of use
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