Serostatus cutoff levels and fold increase to define seroresponse to recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein vaccine: An evidence-based analysis.
Vaccine
; 38(31): 4885-4891, 2020 06 26.
Article
em En
| MEDLINE
| ID: mdl-32499064
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Doença pelo Vírus Ebola
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Vacinas contra Ebola
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Ebolavirus
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Estomatite Vesicular
Tipo de estudo:
Clinical_trials
/
Systematic_reviews
Limite:
Animals
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Humans
País como assunto:
Africa
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article