Coagulation and inflammatory response after intramuscular or intradermal mRNA-1273 SARS-CoV-2 vaccine: secondary analysis of a randomized trial.

Autor: van Dijk WJ; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands., Prins MLM; Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands., Roukens AHE; Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands., Roozen GVT; Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands., Roestenberg M; Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands., Visser LG; Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands., van Hylckama Vlieg A; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands., Rosendaal FR; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
Jazyk: angličtina
Zdroj: Research and practice in thrombosis and haemostasis [Res Pract Thromb Haemost] 2024 Apr 24; Vol. 8 (3), pp. 102419. Date of Electronic Publication: 2024 Apr 24 (Print Publication: 2024).
DOI: 10.1016/j.rpth.2024.102419
Abstrakt: Background: Fractional-dosed intradermal (i.d.) vaccination produces antibody concentrations above the proposed proxy for protection against severe disease as compared with intramuscular (i.m.) vaccination and may be associated with a decreased prothrombotic effect.
Objectives: To assess changes in coagulation following standard dosed i.m. or fractional-dosed i.d. (one-fifth of i.m.) mRNA-1273 SARS-CoV-2 vaccine and to determine the association between the inflammatory response and coagulation.
Methods: This study was embedded in a randomized controlled trial assessing the immunogenicity of an i.d. fractional-dosed mRNA-1273 vaccine. Healthy participants, aged 18 to 30 years, were randomized (2:1) to receive either 2 doses of i.d. or i.m. vaccine. Blood was drawn prior to first and second vaccination doses and 1 and 2 weeks after the second dose. The outcomes were changes in coagulation parameters (primary endpoint peak height of the thrombin generation curve) and inflammation (high-sensitivity C-reactive protein [hs-CRP]).
Results: One hundred twenty-three participants were included (81 i.d.; 42 i.m.). Peak height increased after vaccination (i.m., 28.8 nmol; 95% CI, 6.3-63.8; i.d., 17.3 nmol; 95% CI, 12.5-47.2) and recovered back to baseline within 2 weeks. I.m. vaccination showed a higher inflammatory response compared with i.d. vaccination (extra increase hs-CRP, 0.92 mg/L; 95% CI, 0.2-1.7). Change in endogenous thrombin potential was associated with change in hs-CRP (beta, 28.0; 95% CI, 7.6-48.3).
Conclusion: A transient increase in coagulability after mRNA-1273 SARS-CoV-2 vaccination occurred, which was associated with the inflammatory response. While i.d. administration showed antibody concentrations above the proposed proxy for protection against severe disease, it was associated with less systemic inflammation. Hence, i.d. vaccination may be safer.
(© 2024 The Author(s).)
Databáze: MEDLINE
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