Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial.
Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial.
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DOI：
10.1038/s41591-021-01677-z
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发表时间：
2022-03
期刊：
影响因子：
82.9
通讯作者：
Zhu F
中科院分区：
文献类型：
--
作者：
Li J;Hou L;Guo X;Jin P;Wu S;Zhu J;Pan H;Wang X;Song Z;Wan J;Cui L;Li J;Chen Y;Wang X;Jin L;Liu J;Shi F;Xu X;Zhu T;Chen W;Zhu F
严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）变异体的出现和疫苗引发的中和抗体的减弱表明，最初接受CoronaVac的个人可能需要额外的2019冠状病毒病（COVID-19）疫苗剂量。我们在一项正在进行的、随机、双盲、平行对照的4期试验（NCT 04892459）中，在既往接种过CoronaVac的成人中评估了重组5型腺病毒（AD 5）载体COVID-19疫苗Convidecia作为异源加强疫苗与CoronaVac作为同源加强疫苗的安全性和免疫原性。在过去3-6个月内接受过两剂CoronaVac的成年人接种了Convidecia（n = 96）或CoronaVac（n = 102）。在过去1-3个月内接受过一剂CoronaVac的成年人也接种了Convidecia（n = 51）或CoronaVac（n = 50）。共同主要终点为接种后28 d内不良反应的发生率和加强接种后14 d抗野生型SARS-CoV-2活病毒中和抗体的几何平均滴度（GMT）。接种疫苗后的不良反应在Convidecia接种者中明显更常见，但在所有治疗组中通常为轻度至中度。在先前接受过一次或两次CoronaVac剂量的参与者中，与CoronaVac同源加强相比，Convidecia的异源加强引起了SARS-CoV-2中和抗体GMT的显著增加。这些数据表明，在用CoronaVac初始接种后用Convidecia进行异源加强是安全的，并且比同源加强更具免疫原性。在一剂或两剂灭活SARS-CoV-2疫苗CoronaVac后，用Convidecia（一种重组5型腺病毒载体的COVID-19疫苗）进行异源疫苗接种比同源疫苗接种更具反应原性，但产生的中和抗体水平显著更高。
The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the waning of vaccine-elicited neutralizing antibodies suggests that additional coronavirus disease 2019 (COVID-19) vaccine doses may be needed for individuals who initially received CoronaVac. We evaluated the safety and immunogenicity of the recombinant adenovirus type 5 (AD5)-vectored COVID-19 vaccine Convidecia as a heterologous booster versus those of CoronaVac as homologous booster in adults previously vaccinated with CoronaVac in an ongoing, randomized, observer-blinded, parallel-controlled phase 4 trial (NCT04892459). Adults who had received two doses of CoronaVac in the past 3–6 months were vaccinated with Convidecia (n = 96) or CoronaVac (n = 102). Adults who had received one dose of CoronaVac in the past 1–3 months were also vaccinated with Convidecia (n = 51) or CoronaVac (n = 50). The co-primary endpoints were the occurrence of adverse reactions within 28 d after vaccination and geometric mean titers (GMTs) of neutralizing antibodies against live wild-type SARS-CoV-2 virus at 14 d after booster vaccination. Adverse reactions after vaccination were significantly more frequent in Convidecia recipients but were generally mild to moderate in all treatment groups. Heterologous boosting with Convidecia elicited significantly increased GMTs of neutralizing antibody against SARS-CoV-2 than homologous boosting with CoronaVac in participants who had previously received one or two doses of CoronaVac. These data suggest that heterologous boosting with Convidecia following initial vaccination with CoronaVac is safe and more immunogenic than homologous boosting. Heterologous vaccination with Convidecia, a recombinant adenovirus type 5-vectored COVID-19 vaccine, after one or two doses of CoronaVac, an inactivated SARS-CoV-2 vaccine, is more reactogenic but elicits significantly higher levels of neutralizing antibodies than homologous vaccination.
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DOI：
10.1016/s0140-6736(21)01694-9
发表时间：
2021-09-04
期刊：
Lancet (London, England)
影响因子：
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作者：
Liu X;Shaw RH;Stuart ASV;Greenland M;Aley PK;Andrews NJ;Cameron JC;Charlton S;Clutterbuck EA;Collins AM;Dinesh T;England A;Faust SN;Ferreira DM;Finn A;Green CA;Hallis B;Heath PT;Hill H;Lambe T;Lazarus R;Libri V;Long F;Mujadidi YF;Plested EL;Provstgaard-Morys S;Ramasamy MN;Ramsay M;Read RC;Robinson H;Singh N;Turner DPJ;Turner PJ;Walker LL;White R;Nguyen-Van-Tam JS;Snape MD;Com-COV Study Group
通讯作者：
Com-COV Study Group
DOI：
10.1016/s0140-6736(20)31605-6
发表时间：
2020-08-15
期刊：
Lancet (London, England)
影响因子：
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作者：
Zhu FC;Guan XH;Li YH;Huang JY;Jiang T;Hou LH;Li JX;Yang BF;Wang L;Wang WJ;Wu SP;Wang Z;Wu XH;Xu JJ;Zhang Z;Jia SY;Wang BS;Hu Y;Liu JJ;Zhang J;Qian XA;Li Q;Pan HX;Jiang HD;Deng P;Gou JB;Wang XW;Wang XH;Chen W
通讯作者：
Chen W
影响因子：
15.1
作者：
Victora PC;Castro PMC;Gurzenda S;Medeiros AC;França GVA;Barros PAJD
通讯作者：
Barros PAJD
影响因子：
32.4
作者：
Sallusto F;Lanzavecchia A;Araki K;Ahmed R
通讯作者：
Ahmed R
DOI：
10.1016/s2213-2600(21)00220-4
发表时间：
2021-09
期刊：
The Lancet. Respiratory medicine
影响因子：
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作者：
Lustig Y;Sapir E;Regev-Yochay G;Cohen C;Fluss R;Olmer L;Indenbaum V;Mandelboim M;Doolman R;Amit S;Mendelson E;Ziv A;Huppert A;Rubin C;Freedman L;Kreiss Y
通讯作者：
Kreiss Y