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

被引：1

作者：

Meyer, Brian K. ^{[1
]}

Nahas, Debbie ^{[1
]}

An, Myunggi ^{[1
]}

Danziger, Andrew ^{[1
]}

Smith, Jeffrey ^{[1
]}

Patel, Manish ^{[1
]}

Lin, Shu-An ^{[1
]}

Gleason, Alexa ^{[1
]}

Cox, Kara ^{[1
]}

Capen, Robert ^{[1
]}

Howe, John ^{[1
]}

Bett, Andrew ^{[1
]}

机构：

[1] Merck & Co Inc, West Point, PA 19486 USA

来源：

VACCINE: X | 2024年 / 16卷

关键词：

Vaccine; mRNA/LNP; Jet delivery; RSV; INACTIVATED POLIOVIRUS VACCINE; INTRADERMAL DELIVERY; HEALTHY-ADULTS; OPEN-LABEL; IMMUNOGENICITY; SAFETY; INJECTOR; TOLERABILITY; TRIAL;

D O I：

10.1016/j.jvacx.2023.100420

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 (R), from PharmaJet (R) (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.

引用

页数：7