Trial NCT04758273, ChiCTR2000038804
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=24)
10 mcg KCONVAC D0/14 (n=24) Placebo D0/14 (n=12) |
|
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 |
|
Control
2 IM doses of adjuvant, 14 days apart | |
Participants | |
Randomized 60 participants | |
Characteristics of participants Type of participants: Healthy adults N=60 30 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
Description of participants Healthy adult volunteers, 18 to 59 years of age, 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 Incidence of adverse reactions/events 0-28 days after each dose of vaccination | |
In the report Adverse reactions or AEs within 28 days following the administration of each vaccine dose | |
Variants description | |
Variants | |
Description | |
Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
Yes, Within six months after the trial complete |
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 article, the trial registries were used in data extraction and assessment of risk of bias. The Chinese trial registry was prospective. Protocol and supplementary tables mentioned in the article were not accessible at the time of data extraction. The study reported adverse events primary outcome as pre-stated in the registry. Other safety outcomes were reported as expected. The article reports on two doses (5mcg and 10mcg) on a day 0/14 schedule, whereas the registry records two other schedules for each dose (days 0/28 and days 0/28/56). Therefore, the study (n = 60) did not achieve the sample size recorded in the registry (n = 180). Up to one year follow-up is ongoing.
This study was updated on June 22nd, 2022 after a second publication of the trial report. |