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Abstract
Rare cases of thrombosis with thrombocytopenia syndrome (TTS) have been reported after AZD1222. Anti-platelet factor-4 (PF4) antibodies were observed in patients following presentation of TTS, however it is unclear if AZD1222 was responsible for inducing production of anti-PF4. Paired samples (baseline and day-15) from a phase 3 trial of AZD1222 vs placebo were analyzed for anti-PF4 levels; 19/1727 (1.1%, AZD1222) vs 7/857 (0.8%, placebo) participants were anti-PF4-IgG-negative at baseline but had moderate Day-15 levels (P = 0.676) and 0/35 and 1/20 (5.0%) had moderate levels at baseline but high Day-15 levels. These data indicate that AZD1222 does not induce a clinically relevant general increase in anti-PF4 IgG.
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1 BioPharmaceuticals R&D, AstraZeneca, Microbiome Discovery, Vaccines and Immune Therapies, Gaithersburg, USA (GRID:grid.418152.b) (ISNI:0000 0004 0543 9493)
2 BioPharmaceuticals R&D, AstraZeneca, Translational Medicine, Vaccines and Immune Therapies, Gaithersburg, USA (GRID:grid.418152.b) (ISNI:0000 0004 0543 9493)
3 Biopharmaceuticals R&D, AstraZeneca, Clinical Development, Vaccines and Immune Therapies, Gothenburg, Sweden (GRID:grid.418151.8) (ISNI:0000 0001 1519 6403)
4 BioPharmaceuticals R&D, AstraZeneca, Biometrics, Vaccines and Immune Therapies, Gaithersburg, USA (GRID:grid.418152.b) (ISNI:0000 0004 0543 9493)
5 BioPharmaceuticals R&D, AstraZeneca, Vaccines and Immune Therapies, Gaithersburg, USA (GRID:grid.418152.b) (ISNI:0000 0004 0543 9493)
6 Columbia University Irving Medical Center and New York-Presbyterian Hospital, Division of Infectious Diseases, Department of Medicine, New York, USA (GRID:grid.413734.6) (ISNI:0000 0000 8499 1112)
7 University of Rochester Medical Center, Rochester, USA (GRID:grid.412750.5) (ISNI:0000 0004 1936 9166)