Evidence map›Paper›PMID 40223099›Full record

ArticleCommunications medicine2025

Development of a personalized digital biomarker of vaccine-associated reactogenicity using wearable sensors and digital twin technology.

Steven R Steinhubl, Jadranka Sekaric, Maged Gendy, Huaijian Guo, Matthew P Ward, Craig J Goergen, Jennifer L Anderson, Sarwat Amin, Damen Wilson, Eustache Paramithiotis and 1 more

Abstract read
In one paragraph

Article in Communications medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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

11 authors.

Steven R SteinhublPurdue University, W, Lafayette, IN, USA. ssteinhu@purdue.edu.ORCID http://orcid.org/0000-0002-9256-7914
Jadranka SekaricProlaio Health, Scottsdale, AZ, USA.
Maged GendyProlaio Health, Scottsdale, AZ, USA.
Huaijian GuoCellCarta, Montreal, QC, Canada.
Matthew P WardPurdue University, W, Lafayette, IN, USA.
Craig J GoergenPurdue University, W, Lafayette, IN, USA.
Jennifer L AndersonPurdue University, W, Lafayette, IN, USA.
Sarwat AminPurdue University, W, Lafayette, IN, USA.
Damen WilsonPurdue University, W, Lafayette, IN, USA.
Eustache ParamithiotisCellCarta, Montreal, QC, Canada.
Stephan WegerichProlaio Health, Scottsdale, AZ, USA.

Funding

Indiana Medical Scientist/Engineer Training ProgramT32GM148382 · NIGMS · INDIANA UNIVERSITY INDIANAPOLIS · PI Benjamin Gaston, Emily K Sims · 2023 to 2026
$3.9M
NIGMS NIH HHS T32 GM148382
6 · The paper itself

Abstract

backgroundEffective response to vaccination requires activation of the innate immune system, triggering the synthesis of inflammatory cytokines. The degree of subjective symptoms related to this, referred to as reactogenicity, may predict their eventual immune response. However, the subjective nature of these symptoms is influenced by the nocebo effect, making it difficult to accurately quantify a person's physiologic response. The use of wearable sensors allows for the identification of objective evidence of physiologic changes a person experiences following vaccination, but as these changes are subtle, they can only be detected when an individual's pre-vaccination normal variability is considered.

methodsWe use a wearable torso sensor patch and a machine learning method of similarity-based modeling (SBM) to create a physiologic digital twin for 88 people receiving 104 COVID vaccine doses. By using each individual's pre-vaccine digital twin, we are able to effectively control for expected physiologic variations unique to that individual, leaving only vaccine-induced differences. We use these individualized differences between the pre- and post-vaccine period to develop a multivariate digital biomarker for objectively measuring the degree and duration of physiologic changes each individual experiences following vaccination.

resultsHere we show that the multivariate digital biomarker better predicted systemic reactogenicity than any one physiologic data type and correlated with vaccine-induced changes in humoral and cellular immunity in a 20-person subset.

conclusionsA digital biomarker is capable of objectively identifying an individual's unique response to vaccination and could play a future role in personalizing vaccine regimens.

Identifiers

PMID40223099
PMCPMC11994808

What OpenQuestion holds

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LicenceCC BY
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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.