Covid-19 Living Data

Trial NCT04640402
Publication Meng F, Signal Transduct Tar, 2021

Funding: Public/non profit (Jiangsu Province Centers for Disease Control and Prevention )
Conflict of interest:

Methods
	RCT
	Location : Single center / China Follow-up duration (months): 1.91
	COVID-19 vaccine (Sf9 cells) 20 mcg D0/21 (n=200) COVID-19 vaccine (Sf9 cells) 40 mcg D0/21 (n=200) COVID-19 vaccine (Sf9 cells) 20 mcg D0/14/28 (n=200) COVID-19 vaccine (Sf9 cells) 40 mcg D0/14/28 (n=200) Placebo D0/21 or D0/14/28 n=160)
Inclusion criteria	healthy population aged 18 years or older signed the informed consent had negative HIV and SARS-CoV-2 (IgG and IgM) antibody testing results confirmed by rapid test kit using fingertip blood a negative throat swab for SARS-CoV-2 nucleic acid a clear chest CT image free from imaging features of COVID-19 no significantly abnormal blood routine, blood biochemical, coagulation function and urine routine test results.
Exclusion criteria	Pregnant and breastfeeding women people with allergic history, convulsion, epilepsy, encephalopathy, mental illness, acute infection, severe and uncontrollable cardiovascular disease or other chronic illnesses
Interventions
	Intervention 3 IM doses of 20 mcg at day 0/14/28 2 IM doses of 40 mcg, 22 days apart 2 IM doses of 20 mcg, 22 days apart 3 IM doses of 40 mcg at day 0/14/28
	Control 2 IM injections, 22 days apart or 3 IM injections, 15 days apart from first dose, and 29 days apart from first dose
Participants
	Randomized 960 participants
	Characteristics of participants Type of participants: Healthy volunteers N=960 460 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Healthy adults with no history of COVID-19 in a single centre in China
Primary outcome
	In the register 1. Geometric mean (GMT) of specific antibody [ Time Frame: 1 months after immunization in each study group ] Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA) 2. The incidence of adverse reaction (AR) [ Time Frame: 0 to 7 days after vaccination in each study group ] The incidence of adverse reaction (AR)
	In the report 1. GMT of RBD-specific ELISA antibody responses at 30 days after the last dose vaccination. 2. The incidence of adverse reactions within 7 days after each dose vaccination.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes, All individual data will not be available until the end of the one-year immune persistence observation Data accessibility: Any request for data sharing should be sent to jszfc@vip.sina.com, and will be reviewed and licensed on the basis of scientific merit by the sponsor, investigators and all collaborators. In order to gain access, data sharing applicants need to sign the data access agreement.
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 study registry was used in data extraction and risk of bias assessment.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. They study achieved the sample size specified in the registry.There is no change from the trial registration in the intervention and control treatments. The randomization was made by dose, schedule and age group (18-55; >=56), for the purpose of this review age groups were pooled during extraction.