Evidence map›Paper›PMID 30998735›Full record

Trial reportPloS one2019

Development, qualification, and validation of the Filovirus Animal Nonclinical Group anti-Ebola virus glycoprotein immunoglobulin G enzyme-linked immunosorbent assay for human serum samples.

Thomas L Rudge, Karen A Sankovich, Nancy A Niemuth, Michael S Anderson, Christopher S Badorrek, Nick D Skomrock, Chris M Cirimotich, Carol L Sabourin

Abstract readClinical TrialValidation Study
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed.

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  7. Asymptomatic Malaria Infection and the Immune Response to the 2-Dose Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen in Adults and Children.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Thomas L RudgeBattelle, West Jefferson, OH, United States of America.ORCID 0000-0002-8801-8744
Karen A SankovichBattelle, West Jefferson, OH, United States of America.
Nancy A NiemuthBattelle, West Jefferson, OH, United States of America.
Michael S AndersonBattelle, West Jefferson, OH, United States of America.
Christopher S BadorrekContract support for the U.S. Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) Medical Countermeasures Systems Joint Vaccine Acquisition Program (MCS-JVAP), Fort Detrick, MD, United States of America.
Nick D SkomrockBattelle, West Jefferson, OH, United States of America.
Chris M CirimotichBattelle, West Jefferson, OH, United States of America.
Carol L SabourinBattelle, West Jefferson, OH, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The need for an efficacious vaccine against highly pathogenic filoviruses was reinforced by the recent and devastating 2014-2016 outbreak of Ebola virus (EBOV) disease in Guinea, Sierra Leone, and Liberia that resulted in more than 10,000 casualties. Such a vaccine would need to be vetted through a U.S. Food and Drug Administration (FDA) traditional, accelerated, or Animal Rule or similar European Medicines Agency (EMA) regulatory pathway. Under the FDA Animal Rule, vaccine-induced immune responses correlating with survival of non-human primates (NHPs), or another well-characterized animal model, following lethal EBOV challenge will need to be bridged to human immune response distributions in clinical trials. When possible, species-neutral methods are ideal for detection and bridging of these immune responses, such as methods to quantify anti-EBOV glycoprotein (GP) immunoglobulin G (IgG) antibodies. Further, any method that will be used to support advanced clinical and non-clinical trials will most likely require formal validation to assess suitability prior to use. Reported here is the development, qualification, and validation of a Filovirus Animal Nonclinical Group anti-EBOV GP IgG Enzyme-Linked Immunosorbent Assay (FANG anti-EBOV GP IgG ELISA) for testing human serum samples.

Indexed as

EbolavirusAnimalsAntibodies, ViralEnzyme-Linked Immunosorbent AssayFemaleGlycoproteinsHaplorhiniHemorrhagic Fever, EbolaHumansImmunoglobulin GLiberiaMaleSierra LeoneViral ProteinsAntibodies, ViralGlycoproteinsImmunoglobulin GViral Proteins

Identifiers

PMID30998735
PMCPMC6472792

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.