Medical Science, BioPharmaceuticals, R&D, AstraZeneca, Tokyo, Japan.
Medical Science, BioPharmaceuticals, R&D, AstraZeneca, Osaka, Japan.
Int J Infect Dis. 2022 Jan;114:165-174. doi: 10.1016/j.ijid.2021.10.030. Epub 2021 Oct 22.
Immunogenicity and safety of the AZD1222 (ChAdOx1 nCoV-19) vaccine was evaluated in Japanese adults in an ongoing phase 1/2, randomized, double-blind, parallel-group, placebo-controlled, multi-centre trial (NCT04568031).
Adults (n=256, age ≥18 years) seronegative for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) were stratified by age into 18-55- (n=128), 56-69- (n=86) and ≥70-year-old cohorts (n=42), and randomized 3:1 to receive AZD1222 or placebo (two intramuscular injections 4 weeks apart). Immunogenicity and safety were coprimary endpoints. Data collected up to Day 57 are reported.
Positive seroresponses to SARS-CoV-2 spike and receptor-binding domain antigens were seen in all 174 participants who received two doses of AZD1222. Neutralizing antibody seroresponses were seen in 67.5%, 60.3% and 50.0% of participants receiving AZD1222 aged 18-55, 56-69 and ≥70 years, respectively. Solicited adverse events (AEs) were typically mild/moderate in severity and included pain and tenderness at the injection site, malaise, fatigue, muscle pain and headache. Common unsolicited AEs included pain and tenderness at the injection site, fatigue and elevated body temperature. No vaccine-related serious AEs or deaths were reported.
AZD1222 elicited a strong humoral immune response against SARS-CoV-2, and was well tolerated in Japanese participants, including elderly participants.
在一项正在进行的 1/2 期、随机、双盲、平行组、安慰剂对照、多中心试验（NCT04568031）中，评估了 AZD1222（ChAdOx1 nCoV-19）疫苗在日本成年人中的免疫原性和安全性。
血清学检测 SARS-CoV-2 阴性的成年人（n=256，年龄≥18 岁）按年龄分为 18-55 岁（n=128）、56-69 岁（n=86）和≥70 岁（n=42）三个队列，并按 3:1 随机接受 AZD1222 或安慰剂（两次肌肉注射，间隔 4 周）。免疫原性和安全性是主要终点。报告了截至第 57 天的数据。
所有接受两剂 AZD1222 治疗的 174 名参与者均出现针对 SARS-CoV-2 刺突和受体结合域抗原的阳性血清学反应。接受 AZD1222 治疗的 18-55 岁、56-69 岁和≥70 岁的参与者中，分别有 67.5%、60.3%和 50.0%出现中和抗体血清学反应。大多数不良事件（AEs）为轻度/中度，包括注射部位疼痛和压痛、不适、疲劳、肌肉疼痛和头痛。常见的未报告的 AEs 包括注射部位疼痛和压痛、疲劳和体温升高。未报告与疫苗相关的严重 AEs 或死亡。
AZD1222 在日本参与者中引发了针对 SARS-CoV-2 的强烈体液免疫反应，且耐受性良好，包括老年参与者。
