![]() Similarly, intravenous immunization resulted in lower platelet (24–72 hours) and white blood cell (12–24 hours) counts, and increased neutrophil (2 hours) counts. Intramuscular immunization resulted in transiently lower platelet (12 hours) and white blood cell (12–24 hours) counts relative to vehicle. Spike protein was undetectable by immunohistochemistry 14 days post intramuscular immunization. Intravenous immunization (1x10 9 viral particles) produced higher soluble S1 protein levels with similar expression kinetics. Soluble S1 protein levels decreased within 3 days and were no longer detectable 7–14 days post immunization. S1 subunit cleavage also occurred in vivo and was detectable in sera 12 hours post intramuscular immunization (1x10 10 viral particles) in CD-1 mice. We observed S1 subunit cleavage in vitro following AZD1222 transduction of HEK293x cells. We investigated vaccine-induced S1 subunit cleavage and effects on hematology parameters using AZD1222 (ChAdOx1 nCoV-19), a simian, replication-deficient adenovirus-vectored COVID-19 vaccine. There is limited evidence on whether COVID-19 vaccine-induced spike protein is similarly cleaved and on the immediate effects of vaccination on host immune responses or hematology parameters. High plasma concentrations of S1 subunit are associated with disease progression and respiratory failure during severe COVID-19. The SARS-CoV-2 spike glycoprotein is purported to directly promote platelet activation via the S1 subunit and is cleaved from host cells during infection. Severe COVID-19 can be associated with a prothrombotic state, increasing risk of morbidity and mortality. 8Oncology Safety Pathology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.7Labcorp Early Development Laboratories Limited, Harrogate, United Kingdom.6Microbiome Discovery, Vaccines & Immune Therapies, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, United States.5Translational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, United States.4Regulatory Toxicology and Safety Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Melbourn, United Kingdom.3Research and Development, BioPharmaceuticals R&D, AstraZeneca, Macclesfield, United Kingdom.2Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom. ![]()
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