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2.
JAMA Oncol ; 8(7): 1053-1058, 2022 07 01.
Article in English | MEDLINE | ID: covidwho-1801997

ABSTRACT

Importance: The durability of the antibody response to COVID-19 vaccines in patients with cancer undergoing treatment or who received a stem cell transplant is unknown and may be associated with infection outcomes. Objective: To evaluate anti-SARS-CoV-2 spike protein receptor binding domain (anti-RBD) and neutralizing antibody (nAb) responses to COVID-19 vaccines longitudinally over 6 months in patients with cancer undergoing treatment or who received a stem cell transplant (SCT). Design, Setting, and Participants: In this prospective, observational, longitudinal cross-sectional study of 453 patients with cancer undergoing treatment or who received an SCT at the University of Kansas Cancer Center in Kansas City, blood samples were obtained before 433 patients received a messenger RNA (mRNA) vaccine (BNT162b2 or mRNA-1273), after the first dose of the mRNA vaccine, and 1 month, 3 months, and 6 months after the second dose. Blood samples were also obtained 2, 4, and 7 months after 17 patients received the JNJ-78436735 vaccine. For patients receiving a third dose of an mRNA vaccine, blood samples were obtained 30 days after the third dose. Interventions: Blood samples and BNT162b2, mRNA-1273, or JNJ-78436735 vaccines. Main Outcomes and Measures: Geometric mean titers (GMTs) of the anti-RBD; the ratio of GMTs for analysis of demographic, disease, and treatment variables; the percentage of neutralization of anti-RBD antibodies; and the correlation between anti-RBD and nAb responses to the COVID-19 vaccines. Results: This study enrolled 453 patients (mean [SD] age, 60.4 [13,1] years; 253 [56%] were female). Of 450 patients, 273 (61%) received the BNT162b2 vaccine (Pfizer), 160 (36%) received the mRNA-1273 vaccine (Moderna), and 17 (4%) received the JNJ-7846735 vaccine (Johnson & Johnson). The GMTs of the anti-RBD for all patients were 1.70 (95% CI, 1.04-2.85) before vaccination, 18.65 (95% CI, 10.19-34.11) after the first dose, 470.38 (95% CI, 322.07-686.99) at 1 month after the second dose, 425.80 (95% CI, 322.24-562.64) at 3 months after the second dose, 447.23 (95% CI, 258.53-773.66) at 6 months after the second dose, and 9224.85 (95% CI, 2423.92-35107.55) after the third dose. The rate of threshold neutralization (≥30%) was observed in 203 of 252 patients (80%) 1 month after the second dose and in 135 of 166 patients (81%) 3 months after the second dose. Anti-RBD and nAb were highly correlated (Spearman correlation coefficient, 0.93 [0.92-0.94]; P < .001). Three months after the second dose, anti-RBD titers were lower in male vs female patients (ratio of GMTs, 0.52 [95% CI, 0.34-0.81]), patients older than 65 years vs patients 50 years or younger (ratio of GMTs, 0.38 [95% CI, 0.25-0.57]), and patients with hematologic malignant tumors vs solid tumors (ratio of GMTs, 0.40 [95% CI, 0.20-0.81]). Conclusions and Relevance: In this cross-sectional study, after 2 doses of an mRNA vaccine, anti-RBD titers peaked at 1 month and remained stable over the next 6 months. Patients older than 65 years of age, male patients, and patients with a hematologic malignant tumor had low antibody titers. Compared with the primary vaccine course, a 20-fold increase in titers from a third dose suggests a brisk B-cell anamnestic response in patients with cancer.


Subject(s)
COVID-19 , Neoplasms , 2019-nCoV Vaccine mRNA-1273 , Ad26COVS1 , Antibodies, Neutralizing , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Neoplasms/therapy , Prospective Studies , Stem Cell Transplantation , Vaccines, Synthetic , mRNA Vaccines
5.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-295142

ABSTRACT

Background: Information regarding antibody response to COVID-19 vaccines in cancer patients undergoing therapy is needed for vaccine recommendations and timing of additional doses. This longitudinal study evaluates anti-RBD and neutralizing antibody (NAb) response to COVID-19 vaccines in patients on treatment and post stem cell transplant (SCT).Methods: For mRNA vaccines, anti-RBD and NAb were assessed before vaccination (T0), prior to 2nd dose (T1), 1 month after the 2nd dose (T2), and 3 months after the 2nd dose (T3). For J&J, T1 was 1 month, T2, 2 months and T3, 4 months after vaccine. Primary objective was GMTs of anti-RDB and NAb (%) at above timepoints. Other objectives were a) proportion of patients with anti-RBD ≥100 U/mL, b) correlation between anti-RBD and NAb, c) antibody responses of the 2 mRNA vaccines, and d) anti-RBD in breakthrough COVID-19 cases.Findings: Between 3/2/2021 and 7/30/2021, 438 cancer patients were enrolled. 108 (25%) were post-SCT and 330 (75%) on treatment: 176 (40%) on chemotherapy (C), 21 (5%) on chemoimmunotherapy (C+I), 72 (19%) on immunotherapy (I), and 58 (13%) on targeted oral agents (TOA). 60 % received Pfizer, 36 % Moderna, and 4% J&J. 11·82% of patients had anti-RBD ≥100 U/mL at T0, 25·15% at T1, 75·44 % at T2, and 81·38% at T3. At T3, 84·91% of patients on C, 81·89% on C+I, 86·67% on I, 78·18% post-SCT, and 77·50% on TOA had anti-RBD ≥ 100 U/mL. GMTs were 1·59 at T0, 12·91 at T1, 480·8 at T2 and 439·1 at T3. Neutralization (≥30%) was observed in 14·71%, 38·89%, 80·56% and 81·33% of patients at T0, T1, T2, and T3. There was no difference between the mRNA vaccines. Five patients had breakthrough infection. Four with anti-RBD available had pre-infection anti-RBD <100 U/mL. Interpretation: Four months after SARS-CoV-2 vaccination, ~ 80% of patients on cancer therapy or post-SCT have anti-RBD ≥100 U/mL and ≥30% NAb. Anti-RBD ≥100 U/mL predicts virus neutralization with accuracy. In regions with limited vaccine availability/hesitancy, antibody testing can identify 20% of the patients with relatively low titres for booster prioritization..Funding Information: This work was supported in part by the University of Kansas Cancer Centre and the Investigator Initiated Steering Committee, a grant from the NIGMS (P20 GM130423), and The University of Kansas Cancer Centre Support Grant from the NCI (P30 CA168524). A.K.G. is the Chancellors Distinguished Chair in Biomedical Sciences Endowed. Declaration of Interests: AKG and ZYP are co-founders of Sinochips Diagnostics;PS serves as advisory board member and consultant to Merck, Novartis, Exact Sciences, Seattle Genetics, Immunomedics, Myriad Genetics, AstraZeneca, Puma Biotechnology;JZ served as a scientific advisor/consultant for AstraZeneca, Biodesix, Novocure, Bayer, Daiichi Sankyo, Mirati, Novartis, Cardinal Health, Bristol Myers Squibb, Nexus Health and Sanofi and is on the speakers’ bureau for AstraZeneca and MJH Life Sciences and has received research funding from AstraZeneca, Biodesix, Novartis, Genentech/Roche, Mirati, AbbVie and Hengrui Therapeutics;GCD serves on an advisory board for Novartis;JPM serves as advisory board member and consultant to Novartis, Kite Pharmaceuticals, BMS and Allovir;RAR received institutional support from Bayer, NuCana, Incyte, AstraZeneca, Eureka therapeutics, Merck, Pfizer, and owns stock in Seattle Genetics, Actinium Pharmaceuticals Inc.;MH received consulting fees from Janssen, Pharmacyclics, Novartis Inc., Kite Pharmaceuticals and TG therapeutics. The remaining authors declare no competing interests.Ethics Approval Statement: This study was approved by the Institutional Review Board of the University of Kansas Medical Centre.

7.
JNCI Cancer Spectr ; 5(1): pkaa091, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-1091236
8.
Blood Coagul Fibrinolysis ; 32(4): 294-297, 2021 Jun 01.
Article in English | MEDLINE | ID: covidwho-1066464

ABSTRACT

Factor V inhibitors are a rare cause of life-threatening bleeding. We present a case of an acquired factor V inhibitor likely caused by coronavirus disease 2019 infection. Bleeding was manifested by severe anemia requiring frequent red-cell transfusion, left psoas muscle hematoma, and left retroperitoneal cavity hematoma. Factor V activity was less than 1% and the factor V inhibitor titer was 31.6 Bethesda units. Severe acute respiratory syndrome coronavirus 2 RNA testing of the nasopharynx was positive 2 weeks before presentation and continued to be positive for 30 days. The patient failed treatment with intravenous immunoglobulin and dexamethasone. Three cycles of plasmapheresis with fresh frozen plasma replacement resulted in correction of the bleeding and laboratory coagulopathy. This is the first reported case of a factor V inhibitor in a coronavirus disease 2019 patient and suggests that plasmapheresis may be a successful treatment strategy.


Subject(s)
Autoantibodies/biosynthesis , COVID-19/blood , Factor V/immunology , Hemorrhagic Disorders/etiology , SARS-CoV-2 , Aged, 80 and over , Anemia/etiology , Anemia/therapy , Antibodies, Viral/blood , Antibody Specificity , Autoantibodies/immunology , COVID-19/complications , COVID-19/diagnosis , COVID-19/immunology , Combined Modality Therapy , Comorbidity , Delayed Diagnosis , Dexamethasone/therapeutic use , Erythrocyte Transfusion , Factor V/antagonists & inhibitors , Female , Hematoma/etiology , Hemorrhagic Disorders/drug therapy , Hemorrhagic Disorders/therapy , Humans , Immunoglobulins, Intravenous/therapeutic use , Lupus Coagulation Inhibitor/blood , Octreotide/therapeutic use , Plasma , Plasmapheresis , SARS-CoV-2/immunology , Vitamin K/therapeutic use
9.
Cureus ; 12(7): e9083, 2020 Jul 09.
Article in English | MEDLINE | ID: covidwho-647381

ABSTRACT

A 73-year-old female with past medical history of essential hypertension, hyperlipidemia, seasonal allergies, and chronic back pain presented to the hospital with complaints of headaches, fevers, fatigue, generalized body aches, shortness of breath, and diarrhea. Initial complete blood count was remarkable for leukopenia with an absolute lymph count of 0.60 K/µL and severe thrombocytopenia (platelet count < 3 K/µL). She was tested for COVID-19 via nasopharyngeal swab polymerase chain reaction (PCR) testing and found positive. Additional labs showed an elevated D-dimer, C-reactive protein, fibrinogen, and lactate dehydrogenase. Vitamin B12 and folate levels were obtained and found to be normal. Peripheral smear showed no schistocytes or additional hematologic abnormalities apart from thrombocytopenia. The patient was transfused one unit of platelets with no improvement in platelet count. Fibrinogen count was obtained and found in normal range at 458 mg/dL. Prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR) were all found to be normal. Immune thrombocytopenia purpura (ITP) was suspected and intravenous immunoglobulin (IVIG) was administered at a dose of 1 g/kg/day for two doses. By day 4, the patient had marked response to treatment with platelet recovery to 105 K/µL and subsequently discharged by day 5 with complete resolution of symptoms and platelet count of 146 K/µL. Twenty-eight days after discharge, she presented to hematology clinic with platelet count of 8 K/µL. Repeat nasopharyngeal swab PCR COVID testing was negative and she was treated with IVIG and pulse dexamethasone with prompt response, confirming suspicion of underlying, undiagnosed ITP prior to COVID infection.

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