Evaluation of luciferase and prefusion-stabilized F protein from respiratory syncytial virus mRNA/LNPs in pre-clinical models using jet delivery compared to needle and syringe.

Autor:	Meyer BK; Merck & Co., Inc., West Point, PA, USA., Nahas D; Merck & Co., Inc., West Point, PA, USA., An M; Merck & Co., Inc., West Point, PA, USA., Danziger A; Merck & Co., Inc., West Point, PA, USA., Smith J; Merck & Co., Inc., West Point, PA, USA., Patel M; Merck & Co., Inc., West Point, PA, USA., Lin SA; Merck & Co., Inc., West Point, PA, USA., Gleason A; Merck & Co., Inc., West Point, PA, USA., Cox K; Merck & Co., Inc., West Point, PA, USA., Capen R; Merck & Co., Inc., West Point, PA, USA., Howe J; Merck & Co., Inc., West Point, PA, USA., Bett A; Merck & Co., Inc., West Point, PA, USA.
Jazyk:	angličtina
Zdroj:	Vaccine: X [Vaccine X] 2023 Dec 09; Vol. 16, pp. 100420. Date of Electronic Publication: 2023 Dec 09 (Print Publication: 2024).
DOI:	10.1016/j.jvacx.2023.100420
Abstrakt:	Described here is the evaluation of a luciferase (luc) and respiratory syncytial virus (RSV) messenger RNA / lipid nanoparticle (mRNA/LNP) vaccine using a Needle-free Injection System, Tropis®, from PharmaJet® (Golden, Colorado USA). Needle-free jet delivery offers an alternative to needle/syringe. To perform this assessment, compatibility studies with Tropis were first performed with a luc mRNA/LNP and compared to needle/syringe. Although minor changes in particle size and encapsulation efficiency were observed when using Tropis on the benchtop, in vitro luciferase activity remained the same. Next, the luc mRNA/LNP was administered to rats intramuscularly using Tropis or needle/syringe and tracking of the injection and distribution was performed. Lastly, an mRNA encoding a prefusion-stabilized F protein from RSV was delivered intramuscularly using both Tropis and needle/syringe at 1 and 5 mcg mRNA. An equivalent IgG response was observed using both Tropis and needle/syringe. The cell mediated immune (CMI) response was also evaluated, and responses to RSV-F were detected from animals immunized with needle/syringe at all dose levels, and from the animals immunized with Tropis in the 5 and 25 ug groups. These results indicated that delivery of mRNA/LNPs with Tropis is a potential means of administration and an alternative to needle/syringe. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2023 Merck & Co. Inc. Rahway, NJ,USA and its affiliates. Published by Elsevier Ltd.)
Databáze:	MEDLINE
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