Trial NCT04341389
Publication Zhu F, Lancet, 2020
Dates: 11/04/2020 to 16/04/2020
Funding: Mixed (National Key R&D Programme of China, National Science and Technology Major Project, and CanSino
Biologics.)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / China Follow-up duration (months): 0.92 | |
Ad5-vectored 5×10^10 vp (n=129)
Ad5-vectored 1×10^11 vp (n=253) Placebo (n=126) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
One single IM dose 1 × 10¹¹ vp One single of 5×10¹⁰ vp |
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Control
One single intramascular dose 0 vp | |
Participants | |
Randomized 508 participants | |
Characteristics of participants Type of participants: Healthy volunteers N=508 254 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
Description of participants Healthy adult volunteers with HIV-negative and SARS-CoV-2 infection-free in a single centre in China. | |
Primary outcome | |
In the register Occurrence of adverse reactions [ Time Frame: 0-14 days post vaccination ]Anti SARS-CoV-2 S IgG antibody response(ELISA) [ Time Frame: 28 days post vaccination ]Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 28 days post vaccination ] | |
In the report Incidence of adverse reactions within 14 days after the injection. Geometric mean titres (GMTs) of RBD-specific ELISA antibody responses and neutralising antibody responses against live virus or pseudovirus at day 28 post vaccination. | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, beginning 3 months and ending 1 year after publication. |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Low |
General comment | In addition to the report, the protocol, the statistical plan, the registry were used for the extraction and assessment of bias. This study achieved the ideal sample size. Primary outcome is the same in the registry and the report. No missing data reported. Results for six month data not yet available . |