Trial NCT04756323, ChiCTR2000039462
Publication Pan HX, Chin Med J, 2022

Funding: Private (Beijing Minhai Biological Technology Co., Ltd.)
Conflict of interest: Yes

Methods
RCT
Location : Single center / China
Follow-up duration (months): 1.9
5 mcg KCONVAC D0/14 (n=100)
10 mcg KCONVAC D0/14 (n=100)
Placebo D0/14 (n=50)
5 mcg KCONVAC D0/28 (n=100)
10 mcg KCONVAC D0/28 (n=100)
Placebo D0/28 (n=50)
Inclusion criteria
  • Healthy adults aged 18–59 years
  • seronegative for anti-SARS-CoV-2 IgM and IgG
  • negative for SARS-CoV-2 nucleic acid as confirmed by pharyngeal swab RT-PCR
  • axillary temperature of ≤37.0 °C
  • general good health as established by medical history, physical examination, and laboratory testing
Exclusion criteria
  • Individuals with confirmed cases, suspected cases, or asymptomatic cases of COVID-19
  • close contact with confirmed or suspected cases
  • a history of travel to a foreign or domestic epidemic community within the 14 days before vaccination
  • women who were pregnant or breastfeeding
  • a previous SARS-CoV infection
  • mental disease
  • allergic reaction to any ingredient included in this vaccine or severe allergy to any other vaccine
  • congenital or acquired immune deficiency
  • HIV infection
  • serious systemic disease or other major chronic illness
Interventions
Intervention
2 IM doses of 5 mcg KCONVAC, 14 days apart
2 IM doses of 10 mcg KCONVAC, 14 days apart
2 IM doses of 5 mcg KCONVAC, 28 days apart
2 IM doses of 10 mcg KCONVAC, 28 days apart
Control
2 IM doses of adjuvant, 14 days apart2 IM doses of adjuvant KCONVAC, 28 days apart
Participants
Randomized
500 participants
Characteristics of participants
Type of participants: Healthy adults
N=500
226 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Healthy adult volunteers with no history of COVID-19 and HIV- and SARS-CoV-2 infection-free in a single centre in China.
Primary outcome
In the register
The seropositive rates and level of SARS-CoV-2 neutralizing antibody (Day 28 post full vaccination); The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA) (Day 28 post full vaccination)
In the report
Neutralization antibody seroconversion and RBD-IgG seroconversion at 28 days after administration of the second dose
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, Within six months after the trial complete
Data accessibility: not reported, corresponding authors: Dr. Wen-Jie Tan - tanwj@ivdc.chinacdc.cn; Dr. Wei-Jin Huang - huangweijin@nifdc.org.cn; Dr. Feng-Cai Zhu - jszfc@vip.sina.com
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
Low
General comment In addition to the published paper, the trial registries were used in data extraction and assessment of risk of bias. The registration was recorded as prospective Chinese trial registry; the registry date was one day after start of recruitment, but this likely reflects a delay in processing rather than registration. Protocol and supplementary tables mentioned in the article were not accessible at the time of data extraction. The study reported immunogenicity primary outcome as pre-stated in the registry. Safety outcomes were reported as expected. The article reports on two doses (5mcg and 10mcg) on two schedules (days 0/14 and days 0/28), whereas the registry records a third schedule for each dose (days 0/28/56). The registries also include a comparison of the two different doses versus placebo in adults aged over 59 years. Therefore the study (n = 500) did not achieve the sample size recorded in the registry (n = 1000). Up to one year follow-up is ongoing.
This study was updated on June 22nd, 2022 after a second publication of the trial report.