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Safety and immunogenicity of a third dose of mRNA-1273 vaccine among cancer patients

Cancer Communications 2023年第7期43卷 749-764页

作者： Anna Giuliano Barbara Kuter Shari Pilon-Thomas Junmin Whiting Qianxing Mo Brett Leav Bradley Sirak christopher cubitt christopher Dukes Kimberly Isaacs-Soriano Kayoko Kennedy Somedeb Ball Ning Dong Akriti Jain Patrick Hwu Jeffrey Lancet Department of Cancer Epidemiology Moffitt Cancer CenterTampaFloridaUSA Moderna CambridgeMassachusettsUSA Department of Immunology Moffitt Cancer CenterTampaFloridaUSA Department of Biostatistics and Bioinformatics Moffitt Cancer CenterTampaFloridaUSA Immune Monitoring Core Moffitt Cancer CenterTampaFloridaUSA Non-Therapeutic Research Office(NTRO) Moffitt Cancer CenterTampaFloridaUSA Department of Malignant Hematology Moffitt Cancer CenterTampaFloridaUSA

Background:Compared to the general population,cancer patients are at higher risk of morbidity and mortality following SARS-CoV-2 infection.The immune response to a two-dose regimen ofmRNA vaccines in cancer patients is generally lower than in immunocompetent individuals.Booster doses may meaningfully augment immune response in this population.We conducted an observational study with the primary objective of determining the immunogenicity of vaccine dose three(100μg)of mRNA-1273 among cancer patients and a secondary objective of evaluating safety at 14 and 28 days.Methods:The mRNA-1273 vaccine was administered~7 to 9 months after administering two vaccine doses(i.e.,the primary series).Immune responses(enzyme-linked immunosorbent assay[ELISA])were assessed 28 days post-dose three.Adverse events were collected at days 14(±5)and 28(+5)post-dose three.Fisher exact or X^(2)tests were used to compare SARS-CoV-2 antibody positivity rates,and paired t-tests were used to compare SARS-CoV-2 antibody geometric mean titers(GMTs)across different time intervals.Results:Among 284 adults diagnosed with solid tumors or hematologic malignancies,dose three of mRNA-1273 increased the percentage of patients seropositive for SARS-CoV-2 antibody from 81.7%pre-dose three to 94.4%28 days post-dose three.GMTs increased 19.0-fold(15.8-22.8).Patients with lymphoid cancers or solid tumors had the lowest and highest antibody titers post-dose three,respectively.Antibody responses after dose three were reduced among those who received anti-CD20 antibody treatment,had lower total lymphocyte counts and received anticancer therapy within 3 months.Among patients seronegative for SARS-CoV-2 antibody pre-dose three,69.2%seroconverted after dose three.A majority(70.4%)experienced mostly mild,transient adverse reactions within 14 days of dose three,whereas severe treatment-emergent events within 28 days were very rare(<2%).Conclusion:Dose three of the mRNA-1273 vaccine was well-tolerated and augmented SARS-CoV-2 seropositivity in cancer patients,especi

关键词： Cancer Coronavirus disease 2019 Immunogenicity Observational study Vaccination

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