Evidence map›Paper›PMID 39083770›Full record

Trial reportJournal of medical Internet research2024

Physiological Response to the COVID-19 Vaccine: Insights From a Prospective, Randomized, Single-Blinded, Crossover Trial.

Andjela Markovic, Vladimir Kovacevic, Timo B Brakenhoff, Duco Veen, Paul Klaver, Marianna Mitratza, George S Downward, Diederick E Grobbee, Maureen Cronin, Brianna M Goodale and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2024. 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.

Andjela MarkovicDepartment of Psychology, University of Fribourg, Fribourg, Switzerland.ORCID 0000-0003-2104-9543
Vladimir KovacevicAva Aktiengesellschaft (AG), Zurich, Switzerland.ORCID 0000-0002-9843-6261
Timo B BrakenhoffJulius Clinical, Zeist, Netherlands.ORCID 0000-0003-3543-6296
Duco VeenDepartment of Methodology & Statistics, Utrecht University, Utrecht, Netherlands.ORCID 0000-0002-8352-7574
Paul KlaverJulius Clinical, Zeist, Netherlands.ORCID 0009-0002-8622-1455
Marianna MitratzaJulius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Netherlands.ORCID 0000-0002-1573-2015
George S DownwardJulius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Netherlands.ORCID 0000-0001-6642-7048
Diederick E GrobbeeJulius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Netherlands.ORCID 0000-0003-4472-4468
Maureen CroninAva Aktiengesellschaft (AG), Zurich, Switzerland.ORCID 0000-0003-3208-829X
Brianna M GoodaleAva Aktiengesellschaft (AG), Zurich, Switzerland.ORCID 0000-0002-6450-123X
COVID-19 Remote Early Detection (COVID-RED) consortiumSee Acknowledgments, .

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRapid development and implementation of vaccines constituted a crucial step in containing the COVID-19 pandemic. A comprehensive understanding of physiological responses to these vaccines is important to build trust in medicine.

objectiveThis study aims to investigate temporal dynamics before and after COVID-19 vaccination in 4 physiological parameters as well as the duration of menstrual cycle phases.

methodsIn a prospective trial, 17,825 adults in the Netherlands wore a medical device on their wrist for up to 9 months. The device recorded their physiological signals and synchronized with a complementary smartphone app. By means of multilevel quadratic regression, we examined changes in wearable-recorded breathing rate, wrist skin temperature, heart rate, heart rate variability, and objectively assessed the duration of menstrual cycle phases in menstruating participants to assess the effects of COVID-19 vaccination.

resultsThe recorded physiological signals demonstrated short-term increases in breathing rate and heart rate after COVID-19 vaccination followed by a prompt rebound to baseline levels likely reflecting biological mechanisms accompanying the immune response to vaccination. No sex differences were evident in the measured physiological responses. In menstruating participants, we found a 0.8% decrease in the duration of the menstrual phase following vaccination.

conclusionsThe observed short-term changes suggest that COVID-19 vaccines are not associated with long-term biophysical issues. Taken together, our work provides valuable insights into continuous fluctuations of physiological responses to vaccination and highlights the importance of digital solutions in health care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-021-05241-5.

Indexed as

COVID-19COVID-19 VaccinesCross-Over StudiesHeart RateAdultFemaleHumansMaleMenstrual CycleMiddle AgedNetherlandsProspective StudiesRespiratory RateSARS-CoV-2Single-Blind MethodSkin TemperatureCOVID-19 Vaccinesbiological mechanismbiosignalsbreathing ratedevelopmentdigital healthheart rateimmune responseimplementationmedical devicemenstrual cycleSARS-CoV-2sexvaccinationvaccinevaccine reactogenicitywearableswearable technology

Identifiers

PMID39083770
PMCPMC11325110

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.