Publication Zhang Y, EClinicalMedicine, 2022
Dates: 2022-01-01 to 2022-02-28
Funding: Mixed (Yunnan Provincial Science and Technology Department China ; National Natural Science Foundation of China ; Yunnan Natural Science Foundation ; High-level Health Technical Personnel Project of Yunnan Province ; Spring City Plan: The High-level Talent Promotion and Training Project of Kunming ; Vaccines and placebo were provided by the Walvax Biotechnology Co., Ltd and the SinoVac Biotech Co., Ltd., Beijing, China. )
Conflict of interest: Yes
Single center / China |
Follow-up duration (months): 3
|5 x 10^10 vp ChAdTS-S (n=50)
30 mcg RQ3013 (n=50)
25 mcg ZR202-CoV (n=50)
3 mcg CoronaVac(n=50)
1 IM dose of ChAdTS-S (5×1010 viral particles per 0.5 mL), 100-270 days after CoronaVac primary series.
1 IM dose of RQ3013 (30 mcg per 0.15 mL), 100-270 days after CoronaVac primary series.
1 IM dose of ZR202-CoV (25 mcg per 0.5mL), 100-270 days after CoronaVac primary series.
1 IM dose of CoronaVac (600 antigen units per 0.5 mL), 100-270 days after CoronaVac primary series.
1 IM dose of placebo, 100-270 days after CoronaVac primary series.
|Characteristics of participants|
Type of participants: Adults
Pregnant women: 0
Immunocompromized patients: 0
Age range: NR
|Description of participants|
Adults aged 18-59, healthy or with stable pre-existing disease and with no history of SARS-CoV-2 infection, at a single center in China.
|In the register|
1) Outcome：Neutralizing antibody titers; Measure time point of outcome：The 7th, 14th, 28th days after the third dose of vaccination; Measure method：Micro-cytopathic effect neutralization test (MCPENT) 2) Outcome：Incidence of adverse events; Measure time point of outcome：From the third dose of vaccine to 45 minutes, 0 to 14 days; Measure method：Clinical analysis 3) Outcome：Cellular immune response to SARS-CoV-2; Measure time point of outcome：The 7th, 14th, 28th, 90th and 180th days after the third dose of vaccination; Measure method：Enzyme-linked immunospot assay and flow cytometry analysis.
|In the report|
The geometric mean titres (GMTs) of neutralising antibodies against the wild-type, delta and omicron variants of live SARS-CoV-2 at day 0 (pre-vaccination), 7, 14, and 28 after boosting vaccination ; the occurrence of adverse events within 14 days after the booster vaccination.
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 published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcomes in the article reflect those in the registries. The article presented preliminary analyses for a study with ongoing follow-up. GMTs of serum SARS-CoV-2 receptor binding domain (RBD)-specific IgG were listed as a secondary outcome in the protocol, but were not reported in the paper. The trial (n = 250) achieved its target sample size (n = 250).|