Homologous and Heterologous Covid-19 Booster Vaccinations.
Homologous and Heterologous Covid-19 Booster Vaccinations.
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Homeland and Heteropathy Covid-19加强疫苗接种。
DOI：
10.1056/nejmoa2116414
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发表时间：
2022-03-17
期刊：
影响因子：
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通讯作者：
DMID 21-0012 Study Group
中科院分区：
文献类型：
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作者：
Atmar RL;Lyke KE;Deming ME;Jackson LA;Branche AR;El Sahly HM;Rostad CA;Martin JM;Johnston C;Rupp RE;Mulligan MJ;Brady RC;Frenck RW Jr;Bäcker M;Kottkamp AC;Babu TM;Rajakumar K;Edupuganti S;Dobrzynski D;Coler RN;Posavad CM;Archer JI;Crandon S;Nayak SU;Szydlo D;Zemanek JA;Dominguez Islas CP;Brown ER;Suthar MS;McElrath MJ;McDermott AB;O'Connell SE;Montefiori DC;Eaton A;Neuzil KM;Stephens DS;Roberts PC;Beigel JH;DMID 21-0012 Study Group
虽然在美国获得紧急使用授权的三种针对2019冠状病毒病（Covid-19）的疫苗非常有效，但突破性感染正在发生。需要在完全接种疫苗的受者中连续使用同源加强剂（与一级疫苗相同）和异源加强剂（与一级疫苗不同）的数据。在这项在美国10个地点进行的1-2期开放标签临床试验中，至少提前12周完成Covid-19疫苗方案且没有报告严重急性呼吸系统综合征冠状病毒2病史的成年人（SARS-CoV-2）感染者接受了三种疫苗之一的加强注射：mRNA-1273（Moderna），剂量为100 μg，Ad 26. COV 2. S（约翰逊& Johnson-Janssen），剂量为5×1010个病毒颗粒，或BNT 162 b2（Pfizer-BioNTech），剂量为30 μg。主要终点是试验第15天和第29天的安全性、反应原性和体液免疫原性。在入组试验的458名参与者中，154名接受了mRNA-1273，150名接受了Ad26.COV2.S，153名接受了BNT 162 b2作为加强疫苗; 1名参与者没有接受指定的疫苗。反应原性与主要系列报告的相似。超过一半的接受者报告有注射部位疼痛，不适，头痛或肌痛。对于所有组合，针对SARS-CoV-2 D 614 G假病毒的抗体中和滴度增加了4至73倍，结合滴度增加了5至55倍。同源加强剂使中和抗体滴度增加4至20倍，而异源加强剂使滴度增加6至73倍。除了同源的Ad26.COV2.S-加强的亚组外，所有亚组的刺突特异性T细胞应答均增加。CD 8 + T细胞水平在Ad26.COV2.S致敏的受体中更持久，并且用Ad26.COV2.S疫苗进行异源加强显著增加了mRNA疫苗受体中的尖峰特异性CD 8 + T细胞。同种和异种加强疫苗具有可接受的安全性特征，并且在至少12周前完成主要Covid-19疫苗方案的成人中具有免疫原性。（由国家过敏和传染病研究所资助; DMID 21-0012 ClinicalTrials.gov编号，NCT 04889209。
Although the three vaccines against coronavirus disease 2019 (Covid-19) that have received emergency use authorization in the United States are highly effective, breakthrough infections are occurring. Data are needed on the serial use of homologous boosters (same as the primary vaccine) and heterologous boosters (different from the primary vaccine) in fully vaccinated recipients. In this phase 1–2, open-label clinical trial conducted at 10 sites in the United States, adults who had completed a Covid-19 vaccine regimen at least 12 weeks earlier and had no reported history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received a booster injection with one of three vaccines: mRNA-1273 (Moderna) at a dose of 100 μg, Ad26.COV2.S (Johnson & Johnson–Janssen) at a dose of 5×1010 virus particles, or BNT162b2 (Pfizer–BioNTech) at a dose of 30 μg. The primary end points were safety, reactogenicity, and humoral immunogenicity on trial days 15 and 29. Of the 458 participants who were enrolled in the trial, 154 received mRNA-1273, 150 received Ad26.COV2.S, and 153 received BNT162b2 as booster vaccines; 1 participant did not receive the assigned vaccine. Reactogenicity was similar to that reported for the primary series. More than half the recipients reported having injection-site pain, malaise, headache, or myalgia. For all combinations, antibody neutralizing titers against a SARS-CoV-2 D614G pseudovirus increased by a factor of 4 to 73, and binding titers increased by a factor of 5 to 55. Homologous boosters increased neutralizing antibody titers by a factor of 4 to 20, whereas heterologous boosters increased titers by a factor of 6 to 73. Spike-specific T-cell responses increased in all but the homologous Ad26.COV2.S-boosted subgroup. CD8+ T-cell levels were more durable in the Ad26.COV2.S-primed recipients, and heterologous boosting with the Ad26.COV2.S vaccine substantially increased spike-specific CD8+ T cells in the mRNA vaccine recipients. Homologous and heterologous booster vaccines had an acceptable safety profile and were immunogenic in adults who had completed a primary Covid-19 vaccine regimen at least 12 weeks earlier. (Funded by the National Institute of Allergy and Infectious Diseases; DMID 21-0012 ClinicalTrials.gov number, NCT04889209.)