Evidence map›Paper›PMID 38932244›Full record

ArticleViruses2024

Development and Validation of an Enzyme-Linked Immunosorbent Assay-Based Protocol for Evaluation of Respiratory Syncytial Virus Vaccines.

Eliel Nham, A-Yeung Jang, Hyun Jung Ji, Ki Bum Ahn, Joon-Yong Bae, Man-Seong Park, Jin Gu Yoon, Hye Seong, Ji Yun Noh, Hee Jin Cheong and 3 more

Abstract readValidation Study
In one paragraph

Article in Viruses, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

13 authors.

Eliel NhamDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, Republic of Korea.
A-Yeung JangDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, Republic of Korea.ORCID 0000-0002-4050-2107
Hyun Jung JiKorea Atomic Energy Research Institute, Jeongeup 56212, Republic of Korea.
Ki Bum AhnKorea Atomic Energy Research Institute, Jeongeup 56212, Republic of Korea.
Joon-Yong BaeVaccine Innovation Center-KU Medicine (VIC-K), Seoul 02841, Republic of Korea.
Man-Seong ParkVaccine Innovation Center-KU Medicine (VIC-K), Seoul 02841, Republic of Korea.
Jin Gu YoonDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, Republic of Korea.
Hye SeongDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, Republic of Korea.
Ji Yun NohDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, Republic of Korea.
Hee Jin CheongDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, Republic of Korea.
Woo Joo KimDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, Republic of Korea.ORCID 0000-0002-4546-3880
Ho Seong SeoKorea Atomic Energy Research Institute, Jeongeup 56212, Republic of Korea.ORCID 0000-0002-7103-1344
Joon Young SongDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, Republic of Korea.ORCID 0000-0002-0148-7194

Funding

Ministry of Food and Drug Safety 21172MFDS179
6 · The paper itself

Abstract

Recently, respiratory syncytial virus (RSV) vaccines based on the prefusion F (pre-F) antigen were approved in the United States. We aimed to develop an enzyme-linked immunosorbent assay (ELISA)-based protocol for the practical and large-scale evaluation of RSV vaccines. Two modified pre-F proteins (DS-Cav1 and SC-TM) were produced by genetic recombination and replication using an adenoviral vector. The protocol was established by optimizing the concentrations of the coating antigen (pre-F proteins), secondary antibodies, and blocking buffer. To validate the protocol, we examined its accuracy, precision, and specificity using serum samples from 150 participants across various age groups and the standard serum provided by the National Institute of Health. In the linear correlation analysis, coating concentrations of 5 and 2.5 μg/mL of DS-Cav1 and SC-TM showed high coefficients of determination (r > 0.90), respectively. Concentrations of secondary antibodies (alkaline phosphatase-conjugated anti-human immunoglobulin G, diluted 1:2000) and blocking reagents (5% skim milk/PBS-T) were optimized to minimize non-specific reactions. High accuracy was observed for DS-Cav1 (r = 0.90) and SC-TM (r = 0.86). Further, both antigens showed high precision (coefficient of variation < 15%). Inhibition ELISA revealed cross-reactivity of antibodies against DS-Cav1 and SC-TM, but not with the attachment (G) protein.

Indexed as

Antibodies, ViralEnzyme-Linked Immunosorbent AssayRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAdolescentAdultAgedAntigens, ViralChildChild, PreschoolFemaleHumansInfantMaleMiddle AgedAntibodies, ViralAntigens, ViralRespiratory Syncytial Virus VaccinesViral Fusion ProteinsELISAimmunogenicityrespiratory syncytial virusRSVvaccine

Identifiers

PMID38932244
PMCPMC11209066

What OpenQuestion holds

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Registered trials

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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.