Division of Clinical Hematology, Hematology Department, Hospital Clínico Universitario de Valencia, Avda Blasco Ibañez, 17, 46010, Valencia, Spain.
Fundación INCLIVA, Instituto de Investigación Sanitaria Hospital Clínico Universitario de Valencia, Valencia, Spain.
J Hematol Oncol. 2022 May 7;15(1):54. doi: 10.1186/s13045-022-01275-7.
The clinical efficacy of SARS-CoV-2 vaccines according to antibody response in immunosuppressed patients such as hematological patients has not yet been established.
A prospective multicenter registry-based cohort study conducted from December 2020 to December 2021 by the Spanish transplant and cell therapy group was used to analyze the relationship of antibody response at 3-6 weeks after full vaccination (2 doses) with breakthrough SARS-CoV-2 infection in 1394 patients with hematological disorders.
At a median follow-up of 165 days after complete immunization, 37 out of 1394 (2.6%) developed breakthrough SARS-CoV-2 infection at median of 77 days (range 7-195) after full vaccination. The incidence rate was 6.39 per 100 persons-year. Most patients were asymptomatic (19/37, 51.4%), whereas only 19% developed pneumonia. The mortality rate was 8%. Lack of detectable antibodies at 3-6 weeks after full vaccination was the only variable associated with breakthrough infection in multivariate logistic regression analysis (Odds Ratio 2.35, 95% confidence interval 1.2-4.6, p = 0.012). Median antibody titers were lower in cases than in non-cases [1.83 binding antibody units (BAU)/mL (range 0-4854.93) vs 730.81 BAU/mL (range 0-56,800), respectively (p = 0.007)]. We identified 250 BAU/mL as a cutoff above which incidence and severity of the infection were significantly lower.
Our study highlights the benefit of developing an antibody response in these highly immunosuppressed patients. Level of antibody titers at 3 to 6 weeks after 2-dose vaccination links with protection against both breakthrough infection and severe disease for non-Omicron SARS-CoV-2 variants.
根据抗体应答，在诸如血液病患者等免疫抑制患者中，SARS-CoV-2 疫苗的临床疗效尚未确定。
2020 年 12 月至 2021 年 12 月，西班牙移植和细胞治疗组进行了一项前瞻性多中心基于注册的队列研究，该研究分析了 1394 例血液病患者在完全接种（2 剂）后 3-6 周的抗体应答与突破性 SARS-CoV-2 感染之间的关系。
在完全免疫接种后中位数为 165 天的随访中，1394 例患者中有 37 例（2.6%）在完全接种后中位数为 77 天（范围为 7-195）时发生突破性 SARS-CoV-2 感染。发病率为每 100 人年 6.39 例。大多数患者无症状（19/37，51.4%），而仅有 19%发展为肺炎。死亡率为 8%。在多变量逻辑回归分析中，完全接种后 3-6 周时无法检测到抗体是与突破性感染相关的唯一变量（优势比 2.35，95%置信区间 1.2-4.6，p=0.012）。在病例组中，抗体滴度中位数低于非病例组[1.83 个结合抗体单位（BAU）/mL（范围 0-4854.93）与 730.81 BAU/mL（范围 0-56800），分别（p=0.007）]。我们确定 250 BAU/mL 为一个截断值，高于该值时，感染的发生率和严重程度显著降低。
我们的研究强调了在这些高度免疫抑制患者中产生抗体应答的益处。两剂疫苗接种后 3 至 6 周的抗体滴度与非奥密克戎 SARS-CoV-2 变异株的突破性感染和严重疾病的保护相关。
