Trial ChiCTR2100045107
Publication Shu Y-J, Chin. Med. J., 2021
Dates: 2021-03-30 to 2021-05-26
Funding: Mixed (Livzon Bio Inc., China and the Emergency Key Program of Guangzhou Laboratory)
Conflict of interest: Yes

Methods
RCT
Location : Single center / China
Follow-up duration (months): 1.63
10 mcg 2d. V-01 D0/21 (n=240)
25 mcg 2d. V-01 D0/21 (n=240)
50 mcg 1d. V-01 one dose (n=240)
Adjuvant placebo (n=160)
Inclusion criteria
  • Younger adults aged between 18 and 59 years and older adults over 60 years
  • without a history of either traveling in moderate-to-high risk areas or of contact with confirmed, asymptomatic, or suspected COVID-19 cases
Exclusion criteria
  • A history of COVID-19 or positive COVID19 screening test (reverse transcription polymerase chain reaction or enzyme-linked immunosorbent assay [ELISA]) results
  • a history of SARS
  • autoimmune disease
  • confirmed or suspected immunosuppressive or immunodeficiency disorder
  • known allergic reactions to vaccines or vaccine components
  • any acute febrile disease in the previous 14 days (axillary temperature over 37.3°C)
  • inability to comply with the study protocol as judged by the investigator
Interventions
Intervention
2 IM doses of 10 mcg, 21 days apart
2 IM doses of 25 mcg, 21 days apart
1 IM dose of 50 mcg
Control
2 IM doses of adjuvant placebo, 21 days apart or once off
Participants
Randomized
880 participants
Characteristics of participants
Type of participants: Healthy adults
N=880
479 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Younger (18-59) and older (60+) healthy adults with no current or past SARS-CoV-2 infection (PCR and ELISA) at a single centre in China
Primary outcome
In the register
1. Positive conversion rate of serum anti-SARS-CoV-2 RBD protein antibody, and its geometric mean titer (GMT) and geometric mean fold increase (GMI) (28 days after the last dose); 2. Positive conversion rate of serum anti-SARS-CoV-2 neutralizing antibody, and its GMI (28 days after the last dose)
In the report
1. Seroconversion rate, geometric mean titer (GMT) of the RBD-binding antibody; 2. Seroconversion rate, GMT of the SARS-CoV-2 neutralizing antibody
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes
Data accessibility: The way of sharing IPD: Using a final study report (reported in registry); Corresponding authors: : Wu-Xiang Guan, Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, Hubei 430071, China, E-Mail: guanwx@wh.iov.cn; Zhong-Yu Hu, National Institutes for Food and Drug Control, Beijing 100050, China, E-Mail: huzhy@nifdc.org.cn; Ji-Kai Zhang, Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong, 510440, China, E-Mail: gdswyw_sps@cdcp.org.cn
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 and supplementary appendices were use in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary immunogenicity outcome in the article reflects that in the registry. The extracted safety outcomes were not included in detail in the registry. The trial achieved its target sample size.