1. Serostatus cutoff levels and fold increase to define seroresponse to recombinant vesicular stomatitis virus – Zaire Ebola virus envelope glycoprotein vaccine: An evidence-based analysis.
- Author
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Antonello, Joseph, Grant-Klein, Rebecca J., Nichols, Rick, Kennedy, Stephen B., Dubey, Sheri, and Simon, Jakub K.
- Subjects
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VESICULAR stomatitis , *EBOLA virus , *CLINICAL trial registries , *FISHER exact test , *VACCINES , *GLYCOPROTEINS , *VIRAL envelope proteins - Abstract
• Antibody response correlating with vaccination was used to define seroresponse. • P-values from Fisher's exact test were used to compare definitions of seroresponse. • Two-fold rise and SSCO of 200 EU/mL best differentiated vaccine/placebo recipients. 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. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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