Covid-19 Living Data

Trial ChiCTR2000039462
Publication Liu J, J Infect Dis, 2021

Funding: Public/non profit (Guangdong Emergency Program for Prevention and Control of COVID-19; Shenzhen Key Research Project for Prevention and Control of COVID-19. )
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / China Follow-up duration (months): 2.8
	5mcg KCONVAC (n = 200) 10 mcg KCONVAC (n = 200) Placebo (n = 100)
Inclusion criteria	Aged 18 through 59 years, and 60 years or older seronegative for SARS-CoV-2 immunoglobulin M (IgM) and immunoglobulin G (IgG) and negative for SARS-CoV-2 nucleic acid as confirmed by pharyngeal swab reverse transcription polymerase chain reaction (RT-PCR) axillary temperature of 37.0°C or lower general good health as established by medical history, physical examination, and laboratory testing.
Exclusion criteria	Confirmed cases, suspected cases, or asymptomatic cases of COVID-19 as referred to the Information System of China Disease Prevention and Control close contact with confirmed or suspected cases travel history to a foreign or domestic epidemic community within 14 days before vaccination pregnant or breastfeeding previous SARS-CoV infection mental disease allergic reaction to any ingredient included in this vaccine or severe allergy to any other vaccines congenital or acquired immune deficiency human immunodeficiency virus infection serious systemic diseases other major chronic illnesses.
Interventions
	Intervention 3 IM doses of 5 mcg KCONVAC, each 28 days apart 3 IM doses of 10 mcg KCONVAC, each 28 days apart
	Control 3 IM doses of placebo, each 28 days apart
Participants
	Randomized 500 participants
	Characteristics of participants Type of participants: Healthy adults N=500 241 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Healthy adults aged 18-59 and ≥60 with no history of COVID-19 and seronegative at a single center in China
Primary outcome
	In the register 1) The seropositive rates and level of SARS-CoV-2 neutralizing antibody, Day 28 post full vaccination; 2) The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA), Day 28 post full vaccination
	In the report 1) Neutralization antibody seroconversion and titre 28 days after the third dose; 2) RBD-IgG seroconversion 28 days after the third dose
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: NR Data accessibility: Correspondence: Wen-Jie Tan, PhD (tanwj@ivdc.chinacdc.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	Low
General comment	In addition to the published article, the registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. The primary outcomes in the article reflect those in the registry and protocol. The article presented data through the cutoff of 28 days post the third vaccination with ongoing follow up of safety and antibody persistence as planned. The registry includes an overall sample size of 1000, but this includes two 2-dose regimens not reported in this article; the study (n = 500) achieved its target sample size (n = 100). The 5 mcg dose was selected for further assessment. Quote "Both 5 μg and 10 μg doses elicited similar antibody response in both the age groups. This has supported the EUA for 5 μg dosage instead of 10 μg dosage".