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

Nadine G Rouphael; Lilin Lai; Sonia Tandon; Michele Paine McCullough; Yunchuan Kong; Sarah Kabbani; Muktha S Natrajan; Yongxian Xu; Yerun Zhu; Dongli Wang; Jesse O'Shea; Amy Sherman; Tianwei Yu; Sebastien Henry; Devin McAllister; Daniel Stadlbauer; Surender Khurana; Hana Golding; Florian Krammer; Mark J Mulligan; Mark R Prausnitz

doi:10.1038/s41541-021-00353-0

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

NPJ Vaccines. 2021 Jul 14;6(1):89. doi: 10.1038/s41541-021-00353-0.

Authors

Nadine G Rouphael¹, Lilin Lai², Sonia Tandon^{3

4}, Michele Paine McCullough³, Yunchuan Kong⁴, Sarah Kabbani³, Muktha S Natrajan³, Yongxian Xu³, Yerun Zhu³, Dongli Wang³, Jesse O'Shea³, Amy Sherman³, Tianwei Yu⁴, Sebastien Henry⁵, Devin McAllister⁵, Daniel Stadlbauer⁶, Surender Khurana⁷, Hana Golding⁷, Florian Krammer⁶, Mark J Mulligan⁸, Mark R Prausnitz^{5

9}

Affiliations

¹ Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, School of Medicine, Emory University, Atlanta, Georgia. nroupha@emory.edu.
² Emory Vaccine Center, Department of Pediatrics, School of Medicine, Emory University, Atlanta, Georgia.
³ Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, School of Medicine, Emory University, Atlanta, Georgia.
⁴ Laney Graduate School, Emory University, Atlanta, Georgia.
⁵ Micron Biomedical, Inc., Atlanta, Georgia.
⁶ Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁷ Division of Viral Products Center for Biologics Evaluation and Research, FDA, Silver Spring, MD, USA.
⁸ New York University Langone Medical Center, Alexandria Center for Life Sciences, New York, NY, USA.
⁹ School of Chemical & Biomolecular Engineering, Georgia Institute of Technology, Atlanta, Georgia.

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.

Abstract

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