Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults.

Autor:	Fries, Louis, Cho, Iksung, Krähling, Verena, Fehling, Sarah K, Strecker, Thomas, Becker, Stephan, Hooper, Jay W, Kwilas, Steven A, Agrawal, Sapeckshita, Wen, Judy, Lewis, Maggie, Fix, Amy, Thomas, Nigel, Flyer, David, Smith, Gale, Glenn, Gregory
Předmět:	EBOLA virus NEUTRALIZATION tests VACCINE development IMMUNOGLOBULIN G VIRAL vaccines VACCINES EBOLA virus disease prevention PROTEINS SAFETY RESEARCH IMMUNIZATION IMMUNOGLOBULINS HUMAN research subjects RESEARCH methodology IMMUNOMODULATORS GLYCOSIDES EVALUATION research MEDICAL cooperation COMPARATIVE studies RANDOMIZED controlled trials VIRAL antibodies STATISTICAL sampling NANOPARTICLES
Zdroj:	Journal of Infectious Diseases; 8/15/2020, Vol. 222 Issue 4, p572-582, 11p
Abstrakt:	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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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