Trial ChiCTR2100045108
Publication Liao Y, Emerg Microbes Infec, 2021
Dates: 2021-02-24 to 2021-03-29
Funding: Private (LivzonBio Inc., Emergency Key Program of Guangzhou Laboratory)
Conflict of interest: Yes

Methods
RCT
Location : Single center / China
Follow-up duration (months): 1.7
10 mcg V-01 (n=48)
25 mcg V-01 (n=48)
50 mcg V-01 (n=48)
Adjuvant (n=36)
Inclusion criteria
  • Healthy adults aged over 18 years of age
  • body mass index of 18-28kg/m2
  • without a history of traveling in moderate to high-risk areas
  • nor a history of contact with confirmed, asymptomatic, or suspected COVID-19 patients
Exclusion criteria
  • A history of COVID-19 or tested positive at screening (by RT-PCR or ELISA)
  • a history of SARS, autoimmune diseases, severe allergy reactions to vaccines, congenital or acquired angioneurotic oedema
  • clinically significant abnormal laboratory test
  • allergy to any ingredients of the vaccine
  • confirmed or suspected immunosuppressive or immunodeficiency disorders
  • received any blood products in the past 3 months
  • received any research medicines or vaccines in the past 6 months
  • unable to comply with the study schedule
Interventions
Intervention
2 IM doses of 10 mcg, 21 days apart
2 IM doses of 25 mcg, 21 days apart
2 IM doses of 50 mcg, 21 days apart
Control
2 IM doses of adjuvant, 21 days apart
Participants
Randomized
180 participants
Characteristics of participants
Type of participants: Healthy adults
N=180
114 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Healthy seronegative adults with no history of COVID-19 in a single center in China
Primary outcome
In the register
Safety
In the report
Safety outcomes
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: NR
Data accessibility: Corresponding authors (Jikai Zhang is the leading correspondence): Jikai Zhang, gdswyw_sps@cdcp.org.cn; Zhongyu Hu, huzhy@nifdc.org.cn; Jianfeng He, sjkzx_sws@gd.gov.cn Registry states willing to share IPD, but the report method to share is "Research summary report method" and "Using a final study report"
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 retrospective study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The target sample size specified in the registry was achieved. The safety and immunogenicity outcomes reported in the article are not included in detail in the registry, but are standard vaccine trial outcomes. There is no major difference between the report and the trial registration in the population, intervention and control arms.