Fondazione IRCCS Policlinico San Matteo, Microbiology and Virology Unit, Pavia, Italy,; Specialization School in Microbiology and Virology,University of Pavia, Pavia, Italy..
Department of Public Health, Experimental and Forensic Medicine, Section of Biostatistics and Clinical Epidemiology, University of Pavia, Pavia,Italy; Fondazione IRCCS Policlinico San Matteo, Medical direction, Pavia, Italy.
Vaccine. 2024 Oct 3;42(23):126208. doi: 10.1016/j.vaccine.2024.126208. Epub 2024 Aug 17.
Infection by SARS-CoV2 has become a challenge, especially for immunocompromised patients who show a weaker humoral response to COVID-19 vaccine. Tixagevimab+cilgavimab (Evusheld) is a combination of human monoclonal antibodies that can be used for pre-exposure prophylaxis to prevent infection or disease by SARS-CoV2.
Our study aimed to investigate the effectiveness of Evusheld by comparing an Exposed and an Unexposed group.
Immunocompromised patients were enrolled in the Evusheld Group between March and September 2022. All patients had anti-spike IgG antibody levels <260 BAU/ml before administration of Evusheld. Blood samples for serological evaluations were collected, and anti-Spike antibodies were tested. For the Unexposed Group, a serologic test was performed at enrollment and a questionnaire was performed after 6 months.
43 patients received Evusheld pre-exposure prophylaxis and 45 patients not receiving Evusheld were enrolled in the Unexposed group. The median age was 59.0 years in the Evusheld group, and 63.0 in the unexposed group. In the Evusheld group, during the Omicron wave in Italy, 23.3% of subjects developed symptomatic infection compared to 42.2% in the unexposed group. A majority of infections was seen in male respect to female patients. No difference in length of infection between the groups was seen. Antibody level remained higher than the basal threshold at 180 days from enrollment.
Evusheld seems to reduce the rate of symptomatic infection in immunocompromised patients. Further data are required to determine whether this prophylaxis may have a longer-lasting effect over time.
感染 SARS-CoV2 已成为一个挑战，尤其是对免疫功能低下的患者，他们对 COVID-19 疫苗的体液反应较弱。Tixagevimab+cilgavimab（Evusheld）是一种人源单克隆抗体的组合，可以用于暴露前预防，以预防 SARS-CoV2 的感染或疾病。
我们的研究旨在通过比较暴露组和未暴露组来研究 Evusheld 的有效性。
免疫功能低下的患者于 2022 年 3 月至 9 月期间被纳入 Evusheld 组。所有患者在接受 Evusheld 治疗前抗刺突 IgG 抗体水平<260 BAU/ml。采集血清学评估的血样，并检测抗-Spike 抗体。对于未暴露组，在入组时进行血清学检测，并在 6 个月后进行问卷调查。
43 例患者接受 Evusheld 暴露前预防，45 例未接受 Evusheld 的患者被纳入未暴露组。Evusheld 组的中位年龄为 59.0 岁，未暴露组为 63.0 岁。在意大利的奥密克戎浪潮中，Evusheld 组有 23.3%的患者出现症状性感染，而未暴露组为 42.2%。感染患者大多为男性，而女性患者较少。两组感染持续时间无差异。从入组开始 180 天后，抗体水平仍高于基础阈值。
Evusheld 似乎可降低免疫功能低下患者的症状性感染率。需要进一步的数据来确定这种预防措施是否随着时间的推移具有更长的效果。
