Publication Tang R, Lancet Resp Med, 2023
Dates: 2022-04-23 to 2022-05-23
Funding: Mixed (National Natural Science Foundation of China, Jiangsu Provincial Science Fund for Distinguished Young Scholars, and Jiangsu Provincial Key Project of Science and Technology Plan. Jin-Bo Gou, Haitao Huang, Xiaolong Li, Xue Wang, Peng Wan and Tao Zhu are employees of CanSino Biologics. Tao Zhu owns stock in CanSino Biologics. )
Conflict of interest: Yes
Multicenter / China |
Follow-up duration (months): 0.9
|Inhaled Ad5-nCoV 1.0x10^10 vp (n = 117)
IM Ad5-nCoV 5.0x10^10 vp (n = 120)
3 mcg CoronaVac (n = 119)
1 IN dose of 1.0x10^10 vp in 0.1 ml of aerosolised Ad5-nCoV (2nd booster), at least 6 months (median 6.6) after 3 doses of Coronovac.
1 IM dose of 5.0x10^10 vp in 0.5 ml of Ad5-nCoV (2nd booster), at least 6 months (median 6.6) after 3 doses of Coronovac.
1 IM dose of 3 mcg of Coronovac (2nd booster), at least 6 months (median 6.6) after 3 doses of Coronovac.
|Characteristics of participants|
Type of participants: Healthy adults
Pregnant women: 0
Immunocompromized patients: 0
Age range: NR
|Description of participants|
Healthy adults previously in receipt of 3 doses of CoronaVac and with no history of SARS-CoV-2/COVID-19 in multiple centres in China.
|In the register|
1. Incidence of adverse reactions within 28 days after the booster dose [Time Frame: Within 28 days the booster dose]. 2. GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose [Time Frame: On day 28 after the booster dose].
|In the report|
1. Incidence of adverse reactions occurring within 28 days after the fourth dose. 2. Geometric mean titres (GMTs) for neutralizing antibodies against the live SARS-CoV-2 virus at day 28.
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. Neither protocol, statistical analysis plan nor supplementary appendices were available at the time of extraction. Preliminary analysis, follow-up visits were scheduled up to 6 months after 2nd booster; follow-up after 28 days reported here. The target sample size specified in the registry was achieved. Some outcomes are only reported in figures wihtout complete numbers (e.g., Ab GMT). There is no change from the trial registration in the interventions and control treatments. Report is unclear regarding crossover: "The analysis was based on the modified full-analysis cohort, with some participants reclassified into the correct groups according to the vaccines that they received". This trial was updated on Mars 28th, 2023 after publication of the study report.|