Safety, tolerability, and immunogenicity of measles and rubella vaccine delivered with a high-density microarray patch: results from a randomized, partially double-blinded, placebocontrolled Phase I clinical trial

S. Ben  Baker; Imogen  Bermingham; Indika Leelasena; Julian  Hickling; Paul R Young; Angus  Forster

doi:10.20944/preprints202308.0501.v1

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Safety, tolerability, and immunogenicity of measles and rubella vaccine delivered with a high-density microarray patch: results from a randomized, partially double-blinded, placebocontrolled Phase I clinical trial

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Safety, tolerability, and immunogenicity of measles and rubella vaccine delivered with a high-density microarray patch: results from a randomized, partially double-blinded, placebocontrolled Phase I clinical trial

S. Ben Baker, Imogen Bermingham, Indika Leelasena, Julian Hickling, Paul R Young and Angus Forster

Preprints.org, Vol.7 August 2023

MDPI AG

2023

DOI: https://doi.org/10.20944/preprints202308.0501.v1

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Abstract

microarray patch (MAP)

high-density microarray patch (HD-MAP)

measles (M)

rubella (R)

vaccine

phase I

clinical trial

thermostability

Microarray patches (MAPs) have the potential to be a safer, more acceptable, easier to use, and more cost-effective means for the administration of vaccines than injection by needle and syringe. Here, we report findings from a randomized, partially double-blind, placebo-controlled Phase I trial using the Vaxxas high-density MAP (HD-MAP) to deliver a measles rubella (MR) vaccine. Healthy adults (N = 63, age 18–50 years) were randomly assigned 1:1:1:1 to four groups: uncoated (placebo) HD-MAPs, low-dose MR HD-MAPs (~3,100 median cell-culture infectious dose [CCID50] measles, ~4,300 CCID50 rubella); high dose MR-HD-MAPs (~9,300 CCID50 measles, ~12,900 CCID50 rubella); or a sub-cutaneous (SC) injection of an approved MR vaccine, MR-Vac (≥1,000 CCID50 per virus). The MR vaccines were stable and remained viable on HD-MAPs when stored at 2–8°C for at least 24 months. When MR HD-MAPs stored at 2–8°C for 24 months were transferred to 40°C for 3 days in a controlled temperature excursion, loss of potency was minimal, and MR HD-MAPs still met World Health Organisation (WHO) specifications. MR HD-MAP vaccination was safe and well-tolerated; any systemic or local adverse events (AEs) were mild or moderate. Similar levels of binding and neutralizing antibodies to measles and rubella were induced by low-dose and high-dose MR HD-MAPs and MR-Vac. The neutralizing antibody seroconversion rates at day 28 after vaccination for the low-dose HD-MAP, high-dose HD-MAP and MR-Vac groups were 37.5%, 18.8% and 35.7% respectively for measles and 37.5%, 25.0% and 35.7% respectively for rubella. Most participants were seropositive for measles and rubella antibodies at baseline, which appeared to negatively impact the number of participants that seroconverted to vaccines delivered by either route. The data reported here suggest HD-MAPs could be a valuable means for delivering MR-vaccine to hard-to-reach populations and support further development. Clinical trial registry number: ACTRN12621000820808.

Details

Title: Safety, tolerability, and immunogenicity of measles and rubella vaccine delivered with a high-density microarray patch: results from a randomized, partially double-blinded, placebocontrolled Phase I clinical trial
Authors: S. Ben Baker (Author) - Vaxxas
Imogen Bermingham (Author) - Vaxxas
Indika Leelasena (Author) - University of the Sunshine Coast, Queensland, UniSC Clinical Trials Centre
Julian Hickling (Author) - Tandem Ltd (Cambridge, United Kingdom)
Paul R Young (Author) - The University of Queensland
Angus Forster (Corresponding Author) - Vaxxas
Publication details: Preprints.org, Vol.7 August 2023
Publisher: MDPI AG
Date published: 2023
DOI: 10.20944/preprints202308.0501.v1
ISSN: 2310-287X
Copyright note: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Organisation Unit: UniSC Clinical Trials Centre; University of the Sunshine Coast, Queensland
Language: English
Record Identifier: 99746198802621
Output Type: Preprint

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