Safety of AZD1222 COVID-19 vaccine and low Incidence of SARS-CoV-2 infection in Botswana following ChAdOx1(AZD1222) vaccination: A single-arm open-label interventional study - final study results.
Safety of AZD1222 COVID-19 vaccine and low Incidence of SARS-CoV-2 infection in Botswana following ChAdOx1(AZD1222) vaccination: A single-arm open-label interventional study - final study results.
复制标题
DOI：
10.1016/j.ijregi.2023.11.002
复制
发表时间：
2024-03
期刊：
影响因子：
--
通讯作者：
Moyo, Sikhulile
中科院分区：
文献类型：
--
作者：
Makhema, Joseph;Shava, Emily;Izu, Alane;Gaolathe, Tendani;Kuate, Lesego;Walker, Adam;Carty, Lucy;Georgiou, Panayiotis;Kgathi, Coulson;Choga, Wonderful T.;Sekoto, Tumalano;Seonyatseng, Ngozana;Mogashoa, Tuelo;Maphorisa, Comfort N.;Mohammed, Terence;Ntalabgwe, Tshenolo;Frank, Tshepho T.;Matlhaku, Boitumelo;Diphoko, Ame;Phindela, Thandie;Kaunda, Agripa;Kgari, Poloko;Kanyakula, Thomas;Palalani, Gape;Phakedi, Isabella;Mmalane, Mompati;Taylor, Sylvia;Moyo, Sikhulile
我们确认了 AZD1222 COVID-19 疫苗在博茨瓦纳的安全性。服用两剂 AZD1222 后出现症状的 COVID-19 感染发生率较低。 AZD1222 安全有效。 HIV 状态的免疫反应没有差异。既往感染过 COVID-19 的参与者的不良事件发生率更高。我们观察到先前接触过 COVID-19 的参与者的抗体反应较高。我们报告了 2021 年 9 月至 2022 年 8 月在博茨瓦纳进行的单组开放标签研究的最终分析，该研究评估了博茨瓦纳 AZD1222 疫苗接种后的安全性和 COVID-19 发病率。该研究包括三组成年人（> 18 岁）、同源 AZD1222 初级系列和加强剂 (AZ2)、单剂量 AZD1222 的异源初级系列和 AZD1222 加强剂(HPS)，以及除 AZD1222 和 AZD1222 升压器 (OPS) 以外的主要系列。我们使用精确的比率检验比较了既往感染过和未感染过 COVID-19 的参与者的 AE 发生率。在 10,894 名参与者中，9192 人（84.4%）参加了第一剂疫苗接种，521 人（4.8%）参加了第二剂疫苗接种，1181 人（10.8%）参加了加强疫苗接种。在完整分析集中的 10,855 人中，1700 人接受了一剂 AZD1222； 5377 人接种了两剂； 98 接受了异源系列，包括一个 AZD1222 和一个加强剂； HPS组30个； OPS组1058； AZ2组有2592个。没有实验室确诊的 COVID-19 住院或死亡报告。 AZ2 组实验室确诊的症状性新冠肺炎感染发生率为每 1000 名参与者年 (1000-PY) 6.22 例（95% 置信区间：2.51-12.78），AZ2+ 加强组为每 1000-PY 3.5 例（95% 置信区间：0.42-12.57）。大多数不良事件都很轻微，在既往感染过 COVID-19 的参与者中发生率较高。之前接触过 COVID-19 的个体表现出更高的结合抗体反应。未观察到艾滋病毒状况对结果有差异。 AZD1222 对于感染和未感染艾滋病毒的人来说都是安全、有效且具有免疫原性的。
We confirmed the safety of the AZD1222 COVID-19 vaccine in Botswana. Low incidence of symptomatic COVID-19 infection following two doses of AZD1222. AZD1222 was safe and effective. No differences in immune responses by HIV status. Adverse events were higher in participants with prior COVID-19 infection. We observed higher antibody responses in participants with prior COVID-19 exposure. We report the final analysis of the single-arm open-label study evaluating the safety and COVID-19 incidence after AZD1222 vaccination in Botswana conducted between September 2021 and August 2022. The study included three groups of adults (>18 years), homologous AZD1222 primary series and booster (AZ2), heterologous primary series with one dose AZD1222, and AZD1222 booster (HPS), and primary series other than AZD1222 and AZD1222 booster (OPS). We compared the incidence of AEs in participants with and without prior COVID-19 infection using an exact test for rate ratios. Among 10,894 participants, 9192 (84.4%) were enrolled at first vaccine dose, 521 (4.8%) at second vaccine, and 1181 (10.8%) at the booster vaccine. Of 10,855 included in the full analysis set, 1700 received one dose of AZD1222; 5377 received two doses; 98 received a heterologous series including one AZD1222 and a booster; 30 in the HPS group; 1058 in the OPS group; and 2592 in the AZ2 group. No laboratory-confirmed COVID-19 hospitalizations or deaths were reported. The incidence of laboratory-confirmed symptomatic COVID infection for the AZ2 group was 6.22 (95% confidence interval: 2.51-12.78) per 1000 participant-years (1000-PY) and 3.5 (95% confidence interval: 0.42-12.57) per 1000-PY for AZ2+booster group. Most adverse events were mild, with higher incidence in participants with prior COVID-19 infection. Individuals with prior COVID-19 exposure exhibited higher binding antibody responses. No differences in outcomes were observed by HIV status. AZD1222 is safe, effective, and immunogenic for people living with and without HIV.
登录
查看更多内容
DOI：
10.1016/s0140-6736(20)32661-1
发表时间：
2021-01-09
期刊：
Lancet (London, England)
影响因子：
--
作者：
Voysey M;Clemens SAC;Madhi SA;Weckx LY;Folegatti PM;Aley PK;Angus B;Baillie VL;Barnabas SL;Bhorat QE;Bibi S;Briner C;Cicconi P;Collins AM;Colin-Jones R;Cutland CL;Darton TC;Dheda K;Duncan CJA;Emary KRW;Ewer KJ;Fairlie L;Faust SN;Feng S;Ferreira DM;Finn A;Goodman AL;Green CM;Green CA;Heath PT;Hill C;Hill H;Hirsch I;Hodgson SHC;Izu A;Jackson S;Jenkin D;Joe CCD;Kerridge S;Koen A;Kwatra G;Lazarus R;Lawrie AM;Lelliott A;Libri V;Lillie PJ;Mallory R;Mendes AVA;Milan EP;Minassian AM;McGregor A;Morrison H;Mujadidi YF;Nana A;O'Reilly PJ;Padayachee SD;Pittella A;Plested E;Pollock KM;Ramasamy MN;Rhead S;Schwarzbold AV;Singh N;Smith A;Song R;Snape MD;Sprinz E;Sutherland RK;Tarrant R;Thomson EC;Török ME;Toshner M;Turner DPJ;Vekemans J;Villafana TL;Watson MEE;Williams CJ;Douglas AD;Hill AVS;Lambe T;Gilbert SC;Pollard AJ;Oxford COVID Vaccine Trial Group
通讯作者：
Oxford COVID Vaccine Trial Group
影响因子：
4.6
作者：
通讯作者：
--
影响因子：
56.3
作者：
Madhi, Shabir A.;Kwatra, Gaurav;Richardson, Simone, I;Koen, Anthonet L.;Baillie, Vicky;Cutland, Clare L.;Fairlie, Lee;Padayachee, Sherman D.;Dheda, Keertan;Barnabas, Shaun L.;Bhorat, Qasim Ebrahim;Briner, Carmen;Ahmed, Khatija;Aley, Parvinder K.;Bhikha, Sutika;Bhorat, A. E.;Esmail, Aliasgar;Horne, Elizea;Kaldine, Haajira;Mukendi, Christian K.;Madzorera, Vimbai Sharon;Manamela, Nelia P.;Masilela, Mduduzi;Hermanus, S. Tandile;Motlou, Thopisang;Mzindle, Nonkululeko;Oelofse, Suzette;Patel, Faeezah;Rhead, Sarah;Rossouw, Lindie;Taoushanis, Carol;van Eck, Samuel;Lambe, Teresa;Gilbert, Sarah C.;Pollard, Andrew J.;Moore, Penny L.;Izu, Alane
通讯作者：
Izu, Alane
DOI：
10.1056/nejmoa2105290
发表时间：
2021-12-16
期刊：
The New England journal of medicine
影响因子：
--
作者：
Falsey AR;Sobieszczyk ME;Hirsch I;Sproule S;Robb ML;Corey L;Neuzil KM;Hahn W;Hunt J;Mulligan MJ;McEvoy C;DeJesus E;Hassman M;Little SJ;Pahud BA;Durbin A;Pickrell P;Daar ES;Bush L;Solis J;Carr QO;Oyedele T;Buchbinder S;Cowden J;Vargas SL;Guerreros Benavides A;Call R;Keefer MC;Kirkpatrick BD;Pullman J;Tong T;Brewinski Isaacs M;Benkeser D;Janes HE;Nason MC;Green JA;Kelly EJ;Maaske J;Mueller N;Shoemaker K;Takas T;Marshall RP;Pangalos MN;Villafana T;Gonzalez-Lopez A;AstraZeneca AZD1222 Clinical Study Group
通讯作者：
AstraZeneca AZD1222 Clinical Study Group
影响因子：
8.4
作者：
Niyomnaitham, Suvimol;Jongkaewwattana, Anan;Meesing, Atibordee;Pinpathomrat, Nawamin;Nanthapisal, Sira;Hirankarn, Nattiya;Siwamogsatham, Sarawut;Kirdlarp, Suppachok;Chaiwarith, Romanee;Lawpoolsri, Saranath;Phanthanawiboon, Supranee;Thitithanyanont, Arunee;Hansasuta, Pokrath;Chaiyaroj, Sansanee;Pitisuttithum, Punnee
通讯作者：
Pitisuttithum, Punnee