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Booster Immunisation with Skin-Patch-Delivered Unadjuvanted SARS-CoV-2 Spike Protein Vaccine Is Safe and Immunogenic

Christopher L D McMillan^1,2,3, David A Muller^1,2,3, Germain J P Fernando^1,4

¹School of Chemistry and Molecular Biosciences, The University of Queensland, St. Lucia, Brisbane, QLD 4072, Australia.

|January 28, 2026

Abstract

Background/Objective:

Despite available SARS-CoV-2 vaccines, coverage gaps persist due to unequal distribution and limited access. Microarray patches offer a promising solution to address these challenges, providing a safer and easier-to-use alternative. We present a randomised, double-blind Phase I clinical trial evaluating the SARS-CoV-2 spike protein subunit vaccine, HexaPro, delivered via a high-density microarray patch (HD-MAP).

Methods:

Forty-four healthy adults aged 18-50 years were assigned to receive either 0 µg, 15 µg, or 45 µg of HexaPro via the HD-MAP, with the primary objective of assessing safety and tolerability.

Results:

The HD-MAP HexaPro vaccine was found to be safe and well tolerated, with only mild adverse events reported. Following vaccination significant increases in spike-specific IgG titers were observed by 7 days and remained stable through day 90. This IgG response effectively neutralised multiple SARS-CoV-2 variants. Additionally, the HexaPro HD-MAP was stable for up to 12 months at 40 °C.

Conclusions:

These findings support the continued clinical development of HD-MAPs as an alternative vaccination strategy.

Keywords:

HexaPro SARS-CoV-2 microarray patch microneedles phase 1 clinical trial thermostable vaccine

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