Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia.
Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia.
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DOI：
10.1182/blood.2021011568
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发表时间：
2021-06-10
期刊：
影响因子：
20.3
通讯作者：
Ghia P
中科院分区：
文献类型：
--
作者：
Herishanu Y;Avivi I;Aharon A;Shefer G;Levi S;Bronstein Y;Morales M;Ziv T;Shorer Arbel Y;Scarfò L;Joffe E;Perry C;Ghia P
慢性淋巴细胞性白血病（CLL）患者先前已被证明对抗菌和抗病毒疫苗的反应较差。在本月CME的一篇全会论文中，Herishanu及其同事讨论了167名CLL患者接种COVID-19疫苗的结果，再次证明了疫苗反应明显受损。在接受积极治疗的患者中观察到最低的应答率，而在治疗后完全缓解的患者中观察到最高的应答率;然而，即使是初治患者的应答率也低于健康对照。在该系列中，在接种疫苗后12个月内用抗CD 20抗体治疗的患者中没有获得应答。CLL患者对BNT 162 b2 mRNA COVID-19疫苗的抗体应答明显受损，并受到疾病活动和治疗的影响。在接受布鲁顿酪氨酸激酶抑制剂或维奈托克±抗CD 20抗体治疗的患者中，应答相对较低。慢性淋巴细胞白血病（CLL）患者患严重COVID-19疾病和死亡的风险增加。本研究的目的是确定COVID-19疫苗在CLL患者中的有效性。我们评估了CLL患者对BNT 162 b2信使RNA（mRNA）COVID-19疫苗的体液免疫应答，并将应答与年龄匹配的健康对照受试者进行了比较。患者接受2剂疫苗，间隔21天，并在第二剂接种后使用Elecsys Anti-SARS-CoV-2 S测定法测量抗体滴度。在167例CLL患者中，抗体应答率为39.5%。将52例CLL患者与52例性别和年龄匹配的健康对照者进行比较，发现患者的缓解率显著降低（分别为52%和100%;校正比值比为0.010; 95%置信区间为0.001-0.162; P <0.001）。在治疗后获得临床缓解的患者中应答率最高（79.2%），其次是初治患者的55.2%和接种疫苗时正在治疗的患者的16.0%。在接受布鲁顿酪氨酸激酶抑制剂或维奈托克±抗CD 20抗体治疗的患者中，缓解率相当低（16.0%和13.6%）。在接种疫苗前暴露于抗CD 20抗体<12个月的患者中无一人应答。在多变量分析中，应答的独立预测因素为年龄较小、女性、缺乏当前积极治疗、免疫球蛋白G水平≥550 mg/dL和免疫球蛋白M水平≥40 mg/dL。总之，CLL患者对BNT 162 b2 mRNA COVID-19疫苗的抗体介导的应答明显受损，并受到疾病活动和治疗的影响。该试验在www.clinicaltrials.gov上注册为#NCT 04746092。
Patients with chronic lymphocytic leukemia (CLL) have been previously shown to have poor responses to antibacterial and antiviral vaccines. In a Plenary Paper that is also this month’s CME article, Herishanu and colleagues discuss the outcome of vaccination against COVID-19 in 167 patients with CLL, again demonstrating a significantly impaired vaccine response. The lowest response rates were seen in patients undergoing active treatment, while the highest responses were seen in patients who were in complete remission after therapy; however, even treatment-naïve patients had lower responses than healthy controls. In this series, no responses were achieved in patients treated with anti-CD20 antibodies within 12 months of vaccination. Antibody response to BNT162b2 mRNA COVID-19 vaccine in patients with CLL is markedly impaired and affected by disease activity and treatment. In patients treated with either Bruton’s tyrosine kinase inhibitors or venetoclax ± anti-CD20 antibody, responses are relatively low. Patients with chronic lymphocytic leukemia (CLL) have an increased risk for severe COVID-19 disease and mortality. The goal of this study was to determine the efficacy of COVID-19 vaccine in patients with CLL. We evaluated humoral immune responses to the BNT162b2 messenger RNA (mRNA) COVID-19 vaccine in patients with CLL and compared responses with those obtained in age-matched healthy control subjects. Patients received 2 vaccine doses, 21 days apart, and antibody titers were measured by using the Elecsys Anti-SARS-CoV-2 S assay after administration of the second dose. In a total of 167 patients with CLL, the antibody response rate was 39.5%. A comparison between 52 patients with CLL and 52 sex- and aged-matched healthy control subjects revealed a significantly reduced response rate among patients (52% vs 100%, respectively; adjusted odds ratio, 0.010; 95% confidence interval, 0.001-0.162; P < .001). The response rate was highest in patients who obtained clinical remission after treatment (79.2%), followed by 55.2% in treatment-naive patients and 16.0% in patients under treatment at the time of vaccination. In patients treated with either Bruton’s tyrosine kinase inhibitors or venetoclax ± anti-CD20 antibody, response rates were considerably low (16.0% and 13.6%). None of the patients exposed to anti-CD20 antibodies <12 months before vaccination responded. In a multivariate analysis, the independent predictors of response were younger age, female sex, lack of currently active treatment, immunoglobulin G levels ≥550 mg/dL, and immunoglobulin M levels ≥40 mg/dL. In conclusion, antibody-mediated response to the BNT162b2 mRNA COVID-19 vaccine in patients with CLL is markedly impaired and affected by disease activity and treatment. This trial was registered at www.clinicaltrials.gov as #NCT04746092.
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BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
影响因子：
11.4
作者：
Scarfo, Lydia;Chatzikonstantinou, Thomas;Ghia, Paolo
通讯作者：
Ghia, Paolo
影响因子：
5.5
作者：
Hartkamp, A;Mulder, AHL;Biesma, DH
通讯作者：
Biesma, DH
影响因子：
20.3
作者：
Hallek, Michael;Cheson, Bruce D.;Kipps, Thomas J.
通讯作者：
Kipps, Thomas J.
DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group