Trial NCT04530656
Publication Meng F, Signal Transduct Tar, 2021

Funding: Public/non profit
Conflict of interest:

Methods
RCT
Location : Single center / China
Follow-up duration (months): 1.84
COVID-19 vaccine (Sf9 cells) 20 mcg D0/28 (n=42)
COVID-19 vaccine (Sf9 cells) 40 mcg D0/28 (n=42)
COVID-19 vaccine (Sf9 cells) 40 mcg D0/14/28 (n=42)
Placebo (n=42)
Inclusion criteriaHealthy population aged 18 years or older; sign the informed consent; had negative HIV and SARS-CoV-2 (IgG and IgM) antibody testing results confirmed by rapid test kit using fingertip blood; negative throat swab for SARS-CoV-2 nucleic acid; 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 criteriaPregnant 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
1 IM dose of 20 mcg at D0/28
1 IM dose of 40 mcg at D0/28
1 IM dose of 40 mcg at D0/14/28
Control
1 IM dose at D0/28 or D0/14/28
Participants
Randomized
168 participants
Characteristics of participants
Type of participants: Adults
N=168
82 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
Occurrence of adverse reactions (AR) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. [ Time Frame: 7 days after each dose. ] Occurrence of solicited AR in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
In the report
Incidence of adversereactions within 7 days after each dose vaccination
Variants description
Variants
Description
*
Documents
avalaible

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; >=45), for the purpose of this review age groups were pooled during extraction.