- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
Novavax announces positive top-line data from Phase 1 Ebola vaccine trial
22 July 2015 • Author: Victoria White
Novavax has announced positive top-line data from a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M™.
The trial demonstrated that the Ebola GP Vaccine was highly immunogenic, well-tolerated and, in conjunction with Novavax’ proprietary Matrix-M adjuvant, resulted in significant antigen dose-sparing.
The Ebola GP Vaccine clinical trial is a randomised, observer-blinded, dose-escalation trial to evaluate the safety and immunogenicity of the vaccine, with and without Matrix-M, in 230 healthy adults between 18 and 49 years of age. Participants received either one or two intramuscular injections ranging from 6.5µg to 50µg of antigen on study days 0 and 21. Immunogenicity was assessed at multiple time points including days 28 and 35.
The adjuvanted Ebola GP Vaccine was highly immunogenic at all dose levels. The adjuvanted two-dose regimens induced Ebola anti-GP antibody geometric mean responses between 45,000 and 70,000 ELISA units (GMEU), representing a 500 to 750-fold rise over baseline at day 35. The adjuvanted single dose vaccine regimen induced GMEU between 1700 and 3400, representing a 21 to 27-fold rise over baseline at day 35.
Novavax is also developing vaccine candidates for H7N9 and MERS
“Novavax’ recombinant nanoparticle technology and proprietary Matrix-M adjuvant differentiates our Ebola GP Vaccine. The Phase 1 clinical data show that our vaccine was well-tolerated and elicited very high Ebola antibody responses,” said Gregory Glenn, M.D., Senior Vice President, Research and Development. “These data, together with two positive challenge studies in non-human primates, suggest that the Ebola GP Vaccine would be protective in humans.”
Stanley C. Erck, President and CEO said, “These positive data represent the third time Novavax has leveraged the power of our platform technology to rapidly address an emerging threat. These Ebola GP Vaccine data, in combination with clinical data from our H7N9 VLP vaccine candidate and preclinical data from our vaccine candidate for Middle East Respiratory Syndrome coronavirus, provide additional validation of our nanoparticle vaccine platform. Our Ebola GP Vaccine, adjuvanted with Matrix-M, was highly immunogenic at low doses, allowing for dose-sparing. Further, our recombinant vaccines do not need to be shipped or stored frozen, a key consideration for a vaccine developed against a novel lethal virus with pandemic potential.”
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics