Trial NCT04352608
Publication Zhang Y, Lancet Infect Dis, 2020
Dates: 03/05/2020 to 05/05/2020
Funding: Mixed (National Key Research and Development Program, Beijing Science and Technology Program)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / China Follow-up duration (months): 1.41 | |
• 3 μg at d0/14 (n = 120) • 6 μg at d0/14 (n = 120) • Placebo d0/14 (n = 60) • 3 μg at d0/28 (n = 120) • 6 μg at d0/28 (n = 120) • Placebo d0/28 (n = 60) | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
2 IM doses of 3μg per dose, on days 0, 14 2 IM doses of 6μg per dose, on days 0, 14 2 IM doses of 3μg per dose, on days 0, 28 2 IM doses of 6μg per dose, on days 0, 28 |
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Control
2 IM doses of 0.5 mL aluminum hydroxid per dose, on days 0, 142 IM doses of 0.5 mL aluminum hydroxid per dose, on days 0, 14 | |
Participants | |
Randomized 600 participants | |
Characteristics of participants Type of participants: Healthy volunteers N=600 283 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: 42.1 Age range: NR | |
Description of participants Healthy SARS-CoV-2 serology/DNA negative adults in a single centre in China | |
Primary outcome | |
In the register 1) Safety indexes of adverse reactions [ Time Frame: From the beginning of the vaccination to 28 days after the whole schedule vaccination]; 2) Immunogenicity indexes of neutralizing-antibody seroconversion rates for the emergency vaccination schedule (day 0,14) [ Time Frame: The 14th day after two doses of vaccination]; 3) Immunogenicity indexes of neutralizing-antibody seroconversion rates for the routine vaccination schedule (day 0,28) [ Time Frame: The 28th day after two doses of vaccination ] | |
In the report 1) Any adverse reactions within 28 days after each dose of study drug; 2) Seroconversion of neutralising antibodies to live SARS-CoV-2 at day 14 after the last dose in the days 0 and 14 vaccination cohort, or day 28 after the last dose in the days 0 and 28 vaccination cohort | |
Documents available |
Protocol NR Statistical plan * Data-sharing stated:
Yes, The data will be available immediately after publication and finalisation of the complete clinical study report for at least 6 months |
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 |
Some concerns |
General comment | In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. Study protocol and statistical analysis plan were not available at the time of data extraction. The published article reports on phases 1 and 2 of the trial. Phase 2 achieved the target sample size specified in the trial registry. There were no major differences in population, interventions, or outcomes between the published article and registry. Phase 2 reported on 6 arms where randomization was carried out for high dose vaccine versus low dose vaccine versus placebo but not for shorter versus longer interval duration between doses. |