Journal
JOURNAL OF INFECTIOUS DISEASES
Volume 222, Issue 4, Pages 572-582Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jiz518
Keywords
Ebola virus; glycoprotein; Matrix-M adjuvant; nanoparticle vaccine
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Funding
- US Army Medical Research Institute of Infectious Diseases by the US Department of Defense Medical Countermeasure Systems' Joint Vaccine Acquisition Program
- Novavax, Inc.
- Institute of Virology, Philipps University of Marburg
- US Army Medical Research Institute of Infectious Diseases
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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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