Real-world effectiveness of an intranasal spray A8G6 antibody cocktail in the post-exposure prophylaxis of COVID-19.
Real-world effectiveness of an intranasal spray A8G6 antibody cocktail in the post-exposure prophylaxis of COVID-19.
复制标题
DOI：
10.1038/s41392-023-01656-5
复制
发表时间：
2023-10-23
影响因子：
39.3
通讯作者：
Huang, Ailong
中科院分区：
文献类型：
--
作者：
Li, Xiaosong;Peng, Pai;Deng, Haijun;Yang, Qian;Chen, Shi;Li, Benhua;He, Miao;Jin, Aishun;Yang, Zhu;Tang, Ni;Huang, Ailong
此前，我们发现了一种抗体组合 A8G6，该抗体组合在 COVID-19 动物模型中显示出良好的功效，并在临床前模型以及首次人体试验中显示出良好的安全性。为了评估 A8G6 中和抗体鼻喷雾剂在 COVID-19 暴露后预防中的实际疗效，在中国重庆进行了一项开放标签、非随机、双组、空白对照、研究者发起的试验（注册号：ChiCTR2200066416）。招募与COVID-19患者密切接触后72小时内的高危健康参与者（18-65岁），每天接受三剂（1.4毫克/剂）A8G6治疗或连续7天不接受治疗（空白对照）。空白对照组有 151/340 (44.4%) 名受试者发生 SARS-CoV-2 感染，A8G6 治疗组有 12/173 (6.9%) 名受试者发生感染。经计算，暴露 72 小时内 A8G6 治疗的预防效力为 84.4%（95% CI：74.4-90.4%）。此外，与空白对照组相比，AG86治疗组从SARS-CoV-2阴性到COVID-19阳性转化的时间明显更长（平均时间：3.4天vs 2.6天，p = 0.019）。在次要终点分析中，A8G6 鼻腔治疗对 SARS-CoV-2 RT-PCR 阳性基线时的病毒载量以及 COVID-19 转阴性的时间没有影响。最后，除了 5 名参与者（3.1%）出现一般不良反应外，我们没有观察到任何与 A8G6 治疗相关的严重不良反应。在这项研究中，鼻内喷雾 AG86 抗体混合物显示出对预防 COVID-19 患者密切接触者的 SARS-CoV-2 感染的有效功效。
Previously, we identified an antibody combination A8G6 that showed promising efficacy in COVID-19 animal models and favorable safety profile in preclinical models as well as in a first-in-human trial. To evaluate the real-word efficacy of A8G6 neutralizing antibody nasal spray in post-exposure prophylaxis of COVID-19, an open-label, non-randomized, two-arm, blank-controlled, investigator-initiated trial was conducted in Chongqing, China (the register number: ChiCTR2200066416). High-risk healthy participants (18–65 years) within 72 h after close contact to COVID-19 patients were recruited and received a three-dose (1.4 mg/dose) A8G6 treatment daily or no treatment (blank control) for 7 consecutive days. SARS-CoV-2 infection occurred in 151/340 (44.4%) subjects in the blank control group and 12/173 (6.9%) subjects in the A8G6 treatment group. The prevention efficacy of the A8G6 treatment within 72 h exposure was calculated to be 84.4% (95% CI: 74.4–90.4%). Moreover, compared to the blank-control group, the time from the SARS-CoV-2 negative to the positive COVID-19 conversion was significantly longer in the AG86 treatment group (mean time: 3.4 days vs 2.6 days, p = 0.019). In the secondary end-point analysis, the A8G6 nasal treatment had no effects on the viral load at baseline SARS-CoV-2 RT-PCR positivity and the time of the negative COVID-19 conversion. Finally, except for 5 participants (3.1%) with general adverse effects, we did not observe any severe adverse effects related to the A8G6 treatment. In this study, the intranasal spray AG86 antibody cocktail showed potent efficacy for prevention of SARS-CoV-2 infection in close contacts of COVID-19 patients.
登录
查看更多内容
DOI：
10.1038/s41577-021-00592-1
发表时间：
2021-10
期刊：
Nature reviews. Immunology
影响因子：
--
作者：
Tregoning JS;Flight KE;Higham SL;Wang Z;Pierce BF
通讯作者：
Pierce BF
影响因子：
7.3
作者：
Sharif N;Alzahrani KJ;Ahmed SN;Dey SK
通讯作者：
Dey SK
DOI：
10.1056/nejmoa2119451
发表时间：
2022-04-21
期刊：
The New England journal of medicine
影响因子：
--
作者：
Andrews N;Stowe J;Kirsebom F;Toffa S;Rickeard T;Gallagher E;Gower C;Kall M;Groves N;O'Connell AM;Simons D;Blomquist PB;Zaidi A;Nash S;Iwani Binti Abdul Aziz N;Thelwall S;Dabrera G;Myers R;Amirthalingam G;Gharbia S;Barrett JC;Elson R;Ladhani SN;Ferguson N;Zambon M;Campbell CNJ;Brown K;Hopkins S;Chand M;Ramsay M;Lopez Bernal J
通讯作者：
Lopez Bernal J
DOI：
10.1056/nejmoa2110345
发表时间：
2021-11-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Thomas SJ;Moreira ED Jr;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Polack FP;Zerbini C;Bailey R;Swanson KA;Xu X;Roychoudhury S;Koury K;Bouguermouh S;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Yang Q;Liberator P;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Gruber WC;Jansen KU;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
DOI：
10.1016/s1473-3099(21)00648-4
发表时间：
2022-03
期刊：
The Lancet. Infectious diseases
影响因子：
--
作者：
Singanayagam A;Hakki S;Dunning J;Madon KJ;Crone MA;Koycheva A;Derqui-Fernandez N;Barnett JL;Whitfield MG;Varro R;Charlett A;Kundu R;Fenn J;Cutajar J;Quinn V;Conibear E;Barclay W;Freemont PS;Taylor GP;Ahmad S;Zambon M;Ferguson NM;Lalvani A;ATACCC Study Investigators
通讯作者：
ATACCC Study Investigators