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Serostatus cutoff levels and fold increase to define seroresponse to recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein vaccine: An evidence-based analysis.

Authors
  • Antonello, Joseph1
  • Grant-Klein, Rebecca J2
  • Nichols, Rick3
  • Kennedy, Stephen B4
  • Dubey, Sheri5
  • Simon, Jakub K6
  • 1 Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: [email protected]
  • 2 Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: [email protected]
  • 3 Crozet BioPharma LLC., Devens, MA, USA. Electronic address: [email protected]
  • 4 Partnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia. Electronic address: [email protected] , (Liberia)
  • 5 Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: [email protected]
  • 6 Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: [email protected]
Type
Published Article
Journal
Vaccine
Publication Date
Jun 26, 2020
Volume
38
Issue
31
Pages
4885–4891
Identifiers
DOI: 10.1016/j.vaccine.2020.04.061
PMID: 32499064
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein (rVSVΔG-ZEBOV-GP) vaccine is a live recombinant vesicular stomatitis virus (VSV) where the VSV G protein is replaced with ZEBOV-GP. To better understand the immune response after receiving the rVSVΔG-ZEBOV-GP vaccine, the current analyses evaluated different definitions of seroresponse that differentiate vaccine and placebo recipients enrolled in a placebo-controlled clinical trial (PREVAIL; NCT02344407) in which a subset of the study participants had elevated baseline titers. Alternative values for serostatus cutoff (SSCO; 200-500 EU/mL) and/or fold rise (two- to five-fold) were applied to compare their ability to distinguish between participants receiving rVSVΔG-ZEBOV-GP or placebo. The results indicate that an SSCO of 200 EU/mL can be used to define seropositivity at baseline (i.e. pre-vaccination). The use of dual criteria of the same SSCO (200 EU/mL) together with a two-fold rise in antibody level from baseline provided the definition of seroresponse that maximized the statistical significance between vaccine recipients and placebo recipients post-vaccination. Clinical trial registration: NCT02344407. Copyright © 2020 Elsevier Ltd. All rights reserved.

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