About: Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial

Facets (new session)
Description
Metadata
Settings
- owl:sameAs
- Inference Rule:

About: Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial
Creator	Sutter, Gerd Eickmann, Markus Becker, Stephan Fux, Robert Volz, Asisa Krähling, Verena Kupke, Alexandra Haagmans, Bart Rohde, Cornelius Schmiedel, Stefan Addo, Marylyn Dahlke, Christine Lohse, Ansgar Zinser, Madeleine Fathi, Anahita Okba, Nisreen Halwe, Sandro Bartels, Etienne Borregaard, Saskia Hesterkamp, Thomas Jambrecina, Alen Koch, Till Ly, My Neumann, Reza Poetsch, Joseph
Source	Elsevier; Medline; PMC
abstract	BACKGROUND: The Middle East respiratory syndrome coronavirus (MERS-CoV) causes a respiratory disease with a case fatality rate of up to 35%. Given its potential to cause a public health emergency and the absence of efficacious drugs or vaccines, MERS is one of the WHO priority diseases warranting urgent research and development of countermeasures. We aimed to assess safety and tolerability of an anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine candidate that expresses the MERS-CoV spike glycoprotein, MVA-MERS-S, in healthy adults. METHODS: This open-label, phase 1 trial was done at the University Medical Center Hamburg-Eppendorf (Hamburg, Germany). Participants were healthy men and women aged 18–55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5–30·0 kg/m(2) and weight of more than 50 kg at screening, and a negative pregnancy test for women. A key exclusion criterion was a previous MVA vaccination. For the prime immunisation, participants received doses of 1 × 10(7) plaque-forming unit (PFU; low-dose group) or 1 × 10(8) PFU (high-dose group) MVA-MERS-S intramuscularly. A second identical dose was administered intramuscularly as a booster immunisation 28 days after first injection. As a control group for immunogenicity analyses, blood samples were drawn at identical study timepoints from six healthy adults, who did not receive any injections. The primary objectives of the study were safety and tolerability of the two dosage levels and reactogenicity after administration. Immunogenicity was assessed as a secondary endpoint by ELISA and neutralisation tests. T-cell immunity was evaluated by interferon-γ-linked enzyme-linked immune absorbent spot assay. All participants who were vaccinated at least once were included in the safety analysis. Immunogenicity was analysed in the participants who completed 6 months of follow-up. This trial is registered with ClinicalTrials.gov, NCT03615911, and EudraCT, 2014-003195-23 FINDINGS: From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group) were enrolled and received the first dose of the vaccine according to their group allocation. Of these, 23 participants (12 in the low-dose group and 11 in the high-dose group) received a second dose of MVA-MERS-S according to their group allocation after a 28-day interval and completed follow-up. Homologous prime–boost immunisation with MVA-MERS-S revealed a benign safety profile with only transient mild-to-moderate reactogenicity. Participants had no severe or serious adverse events. 67 vaccine-related adverse events were reported in ten (71%) of 14 participants in the low-dose group, and 111 were reported in ten (83%) of 12 participants in the high-dose group. Solicited local reactions were the most common adverse events: pain was observed in 17 (65%; seven in the low-dose group vs ten in the high-dose group) participants, swelling in ten (38%; two vs eight) participants, and induration in ten (38%; one vs nine) participants. Headaches (observed in seven participants in the low-dose group vs nine in the high-dose group) and fatigue or malaise (ten vs seven participants) were the most common solicited systemic adverse events. All adverse events resolved swiftly (within 1–3 days) and without sequelae. Following booster immunisation, nine (75%) of 12 participants in the low-dose group and 11 (100%) participants in the high-dose group showed seroconversion using a MERS-CoV S1 ELISA at any timepoint during the study. Binding antibody titres correlated with MERS-CoV-specific neutralising antibodies (Spearman's correlation r=0·86 [95% CI 0·6960–0·9427], p=0·0001). MERS-CoV spike-specific T-cell responses were detected in ten (83%) of 12 immunised participants in the low-dose group and ten (91%) of 11 immunised participants in the high-dose group. INTERPRETATION: Vaccination with MVA-MERS-S had a favourable safety profile without serious or severe adverse events. Homologous prime–boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose–effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses. The data presented here support further clinical testing of MVA-MERS-S in larger cohorts to advance MERS vaccine development. FUNDING: German Center for Infection Research.
has issue date	2020-04-21(xsd:dateTime)
bibo:doi	10.1016/s1473-3099(20)30248-6
bibo:pmid	32325037
has license	no-cc
sha1sum (hex)	5e670558d4677a98977bf99daf4945be77494415
schema:url	https://doi.org/10.1016/s1473-3099%2820%2930248-6
resource representing a document's title	Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial
has PubMed Central identifier	PMC7172913
has PubMed identifier	32325037
schema:publication	Lancet Infect Dis
resource representing a document's body	covid:5e670558d4677a98977bf99daf4945be77494415#body_text
is schema:about of	covid:arg/5e670558d4677a98977bf99daf4945be77494415 named entity 'vaccines' named entity 'vaccine' named entity 'respiratory disease' named entity 'MERS-CoV' named entity 'open-label' named entity 'modified vaccinia virus Ankara' named entity 'Germany' named entity 'MERS' named entity 'humoral immune responses' named entity 'vaccination' named entity 'immunogenicity' named entity 'antibodies' named entity 'MERS-CoV' named entity 'immunisation' named entity 'virus' named entity 'fatigue' named entity 'protein' named entity 'MERS coronavirus' named entity 'vector' named entity 'DNA vaccine' named entity 'CRP' named entity 'flowcytometry' named entity 'immunisations' named entity 'MERS-CoV' named entity 'influenza-like' named entity 'signs and symptoms' named entity 'MERS-CoV' named entity 'life-threatening' named entity 'T-cell' named entity 'follow-up' named entity 'neutralising antibody' named entity 'DPP4' named entity 'adverse events' named entity 'prevent disease' named entity 'MERS' named entity 'phase 1 trial' named entity 'vaccines' named entity 'MERS' named entity 'MERS' named entity 'adverse events' named entity 'blood samples' named entity 'vaccine' named entity 'creatinine' named entity 'vector' named entity 'ELISpot' named entity 'cytopathic effects' named entity 'Immunogenicity' named entity 'BD Biosciences' named entity 'cytomegalovirus' named entity 'host cells' named entity 'MERS' named entity 'vaccination' named entity 'vaccine' named entity 'Antigen' named entity 'PFU' named entity 'adverse events'

Faceted Search & Find service v1.13.91 as of Mar 24 2020

Alternative Linked Data Documents: Sponger | ODE Content Formats:

RDF

ODATA

Microdata

About

OpenLink Virtuoso version 07.20.3229 as of Jul 10 2020, on Linux (x86_64-pc-linux-gnu), Single-Server Edition (94 GB total memory)
Data on this page belongs to its respective rights holders.
Virtuoso Faceted Browser Copyright © 2009-2024 OpenLink Software