Evidence map›Paper›PMID 36685004›Full record

ArticleResearch and practice in thrombosis and haemostasis2023

No changes in hemostasis after COVID-19-heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study.

Nora V Butta, Elena G Arias-Salgado, Elena Monzón Manzano, Paula Acuña, María Teresa Álvarez Román, Antonio Buño-Soto, Juan Carlos Ramos Ramos, Cristóbal Belda-Iniesta, Jesús Frías, Antonio J Carcas and 8 more

Open access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 99% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

18 authors at 4 institutions in 2 countries.

Nora V ButtaServicio de Hematología y Hemoterapia, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
Elena G Arias-SalgadoServicio de Hematología y Hemoterapia, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
Elena Monzón ManzanoServicio de Hematología y Hemoterapia, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
Paula AcuñaServicio de Hematología y Hemoterapia, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
María Teresa Álvarez RománServicio de Hematología y Hemoterapia, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Universidad Autónoma de Madrid, Madrid, Spain.
Antonio Buño-SotoServicio de Análisis Clínicos, Hospital Universitario La Paz, Madrid, Spain.
Juan Carlos Ramos RamosUnidad de Enfermedades Infecciosas, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
Cristóbal Belda-IniestaInstituto de Salud Carlos III - ISCIII, Madrid, Spain.
Jesús FríasServicio de Farmacología Clínica, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
Antonio J CarcasServicio de Farmacología Clínica, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
Lucía Martínez de SotoServicio de Farmacología Clínica, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
Rosa de Miguel BuckleyUnidad de Enfermedades Infecciosas, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
David LoraSpanish Clinical Research Network (SCReN-ISCIII), Madrid, Spain.
María Teresa García-MoralesSpanish Clinical Research Network (SCReN-ISCIII), Madrid, Spain.
Alberto M BorobiaServicio de Farmacología Clínica, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Madrid, Spain.
José Ramón ArribasCentro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain.
Víctor Jiménez YusteServicio de Hematología y Hemoterapia, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz, Universidad Autónoma de Madrid, Madrid, Spain.
CombiVacS Study Group
Hospital Universitario La Paz · ESEuropean Union · BEUniversidad Complutense de Madrid · ESInstituto de Salud Carlos III · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Several cases of unusual thrombotic events and thrombocytopenia were described after vaccination with recombinant adenoviral vectors encoding the spike protein antigen of SARS-CoV-2. Objectives: The objective of this study was to elucidate the impact of a COVID-19 heterologous vaccination schedule, including priming with adenovirus vaccine, on hemostasis profiles. Methods: The present study is a subanalysis of the CombiVacS clinical trial initiated in April 2021 that included adult participants previously vaccinated with a single dose of ChAdOx1-S. Between 8 and 12 weeks after vaccination, they were randomly assigned (2:1) to receive either BNT162b2 vaccine (intervention group, Results: Platelet count from all participants after receiving BNT162b2 was within the normal range. Anti-PF4 antibodies were present in 26% and 18% of the subjects from the control and intervention groups, respectively, at day 28. In most cases, the levels of anti-PF4 antibodies were high before receiving BNT162b2. Serum from these participants did not activate platelets from healthy controls. There were no differences between the groups in PAI-1 and cfDNA plasma levels. According to the D-dimer plasma concentration, the thrombin generation test showed that none of the participants had a procoagulant profile. Conclusion: Our data suggest that the heterologous vaccination against COVID-19 with ChAdOx1-S and a second dose with BNT162b2 might be safe in terms of haemostasis.

Indexed as

anti-PF4 antibodiescoagulationCombiVacS studyCOVID-19 vaccinehemostasisheterologous vaccinationthrombocytopenia

Identifiers

PMID36685004
PMCPMC9840220
OpenAlexW4316135920

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.