Virus reduction neutralization test and LI-COR microneutralization assay bridging and WHO international standard calibration studies for respiratory syncytial virus-Reference-Cited by-同舟云学术

Virus reduction neutralization test and LI-COR microneutralization assay bridging and WHO international standard calibration studies for respiratory syncytial virus

Published:2022-08 Issue:15 Volume:14 Page:1067-1079
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Sun Dengyun¹^ORCID,Homan Ying X²,Antonello Joseph M³,Giacone Danila¹,Bogardus Leah¹⁴,Zhang Yuhua³,Feng Wen²,Caro-Aguilar Ivette C²,Hsu Amy¹,Dellatore Shara¹,Whiteman Melissa C¹

Affiliation:

1. Analytical Research & Development, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, NJ 07065, USA

2. Regulated Bioanalytical Immunogenicity & Molecular, Preclinical Development, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, NJ 07065, USA

3. Biometrics Research, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, NJ 07065, USA

4. Current address: Project & Portfolio Management, Pfizer Inc. 235 E 42nd Street, New York, NY 10017, USA

Abstract

Background: Respiratory syncytial virus (RSV) vaccine is an unmet medical need. The virus reduction neutralization test (VRNT) was developed to replace the LI-COR microneutralization assay to measure RSV neutralization titers. Methods: A bridging study using selected V171 phase I samples and calibration studies using the WHO international standard antiserum to RSV were performed to compare VRNT and LI-COR. Results: From the bridging study, we showed good concordance between VRNT and LI-COR titers, and similar post-/prevaccination titer ratios. From the calibration studies, we can convert VRNT and LI-COR titers into similar IU/ml. Conclusion: The VRNT and LI-COR microneutralization assay correlate well and the titers can be standardized as similar IU/ml, enabling direct comparison of titers from different assays.

Funder

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2022-0097

Reference35 articles.

1. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis

2. Respiratory Syncytial Virus Infection

3. An Overview of Respiratory Syncytial Virus

4. Hospitalizations Associated With Influenza and Respiratory Syncytial Virus in the United States, 1993–2008

5. Respiratory Syncytial Virus Infection in Elderly and High-Risk Adults

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Evaluation of a stabilized RSV pre-fusion F mRNA vaccine: Preclinical studies and Phase 1 clinical testing in healthy adults;Vaccine;2023-10