Evidence map›Paper›PMID 36376733›Full record

ArticleInfectious diseases and therapy2023

Quantifying the Vaccine-Induced Humoral Immune Response to Spike-Receptor Binding Domain as a Surrogate for Neutralization Testing Following mRNA-1273 (Spikevax) Vaccination Against COVID-19.

Imke Kirste, Sayuri Hortsch, Veit Peter Grunert, Holly Legault, Maha Maglinao, Udo Eichenlaub, Basel Kashlan, Rolando Pajon, Simon Jochum

Open access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 29% of its field
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

4 citing papers in PubMed, 8 citations in OpenAlex.

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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

9 authors at 4 institutions in 2 countries.

Imke Kirste *Clinical Development & Medical Affairs, Roche Diagnostics Operations, Indianapolis, USA.
Sayuri Hortsch *Biostatistics and Data Science, Roche Diagnostics GmbH, Penzberg, Germany.
Veit Peter GrunertBiostatistics and Data Science, Roche Diagnostics GmbH, Penzberg, Germany.
Holly LegaultClinical Biomarkers, Moderna, Inc, 200 Technology Square, Cambridge, MA, 02139, USA.
Maha MaglinaoClinical Biomarkers, Moderna, Inc, 200 Technology Square, Cambridge, MA, 02139, USA.
Udo EichenlaubClinical Development & Medical Affairs, Roche Diagnostics Operations, Indianapolis, USA.
Basel KashlanLab Operations, PPD, Part of Thermo Fisher Scientific, Highland Heights, KY, USA.
Rolando PajonClinical Biomarkers, Moderna, Inc, 200 Technology Square, Cambridge, MA, 02139, USA. rolando.pajon@modernatx.com.
Simon JochumResearch and Development Immunoassays, Roche Diagnostics GmbH, Nonnenwald 2, 82377, Penzberg, Germany. simon.jochum@roche.com.ORCID http://orcid.org/0000-0002-7296-5229
Moderna Therapeutics (United States) · USRoche (United States) · USRoche Pharma AG (Germany) · DEThermo Fisher Scientific (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere is a need for automated, high-throughput assays to quantify immune response after SARS-CoV-2 vaccination. This study assessed the combined utility of the Elecsys

methodsSamples from 593 healthy participants in two age cohorts (18-54 and ≥ 55 years), who received two injections with placebo (n = 198) or mRNA-1273 (50 μg [n = 197] or 100 μg [n = 198]), were collected at days 1 (first vaccination), 15, 29 (second vaccination), 43, and 57. ACOV2S results were used to assess humoral response to vaccination in different subgroups and were compared to live virus microneutralization assay. Samples from patients with either previous or concomitant infection (identified per ACOV2N) were analyzed separately.

resultsReceptor-binding domain-specific antibodies were readily detectable by ACOV2S for the vast majority of participants (174/189, 92.1% [50 μg dose] and 178/192, 92.7% [100 μg dose]) at the first post-vaccination assessment, with non-converters predominantly older in age. Seroconversion for all participants was observed at day 29 (before the second vaccine dose). Two weeks after the first dose, geometric mean concentration (GMC) of antibody levels was 1.37-fold higher in the 100 versus 50 μg group (p = 0.0098), reducing to 1.09-fold 2 weeks after the second dose (p = 0.0539, n.s.). In both dose groups, a more pronounced response was observed in the younger versus older age group on day 15 (50 μg, 2.49-fold [p < 0.0001]; 100 μg, 3.94-fold [p < 0.0001] higher GMC, respectively), and day 29 (1.93-fold, p = 0.0002, and 2.44-fold, p < 0.0001). Eight subjects had previous or concomitant SARS-CoV-2 infection; vaccination boosted their humoral response to very high ACOV2S results compared to infection-naïve recipients. ACOV2S strongly correlated with microneutralization (Pearson's r = 0.779; p < 0.0001), including good qualitative agreement.

conclusionThese results confirmed that ACOV2S is a highly valuable assay for tracking vaccine-related immune responses. Combined application with ACOV2N enables monitoring for breakthrough infection or stratification of previous natively infected individuals. The adaptive measuring range and high resolution of ACOV2S allow for early identification of seroconversion and resolution of very high titers and longitudinal differences between subgroups. Additionally, good correlation with live virus microneutralization suggests that ACOV2S is a reliable estimate of neutralization capacity in routine diagnostic settings.

Indexed as

COVID-19Live virus microneutralizationQuantitative serologySARS-CoV-2Vaccination

Identifiers

PMID36376733
PMCPMC9663276
OpenAlexW4309198708

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.