Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults.
J Infect Dis
; 222(4): 572-582, 2020 07 23.
Article
em En
| MEDLINE
| ID: mdl-31603201
BACKGROUND: Ebola virus (EBOV) epidemics pose a major public health risk. There currently is no licensed human vaccine against EBOV. The safety and immunogenicity of a recombinant EBOV glycoprotein (GP) nanoparticle vaccine formulated with or without Matrix-M adjuvant were evaluated to support vaccine development. METHODS: A phase 1, placebo-controlled, dose-escalation trial was conducted in 230 healthy adults to evaluate 4 EBOV GP antigen doses as single- or 2-dose regimens with or without adjuvant. Safety and immunogenicity were assessed through 1-year postdosing. RESULTS: All EBOV GP vaccine formulations were well tolerated. Receipt of 2 doses of EBOV GP with adjuvant showed a rapid increase in anti-EBOV GP immunoglobulin G titers with peak titers observed on Day 35 representing 498- to 754-fold increases from baseline; no evidence of an antigen dose response was observed. Serum EBOV-neutralizing and binding antibodies using wild-type Zaire EBOV (ZEBOV) or pseudovirion assays were 3- to 9-fold higher among recipients of 2-dose EBOV GP with adjuvant, compared with placebo on Day 35, which persisted through 1 year. CONCLUSIONS: Ebola virus GP vaccine with Matrix-M adjuvant is well tolerated and elicits a robust and persistent immune response. These data suggest that further development of this candidate vaccine for prevention of EBOV disease is warranted.
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Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Saponinas
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Proteínas do Envelope Viral
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Adjuvantes Imunológicos
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Doença pelo Vírus Ebola
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Vacinas contra Ebola
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Nanopartículas
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Female
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Humans
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Male
País como assunto:
Oceania
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article