Covid-19 Living Data

Trial ChiCTR2000031809
Publication Xia S, JAMA, 2020
Dates: 12/04/2020 to 02/05/2020
Funding: Mixed ( National Program on Key Research Project of China, Major Science and Technology Project of the National New Drug Development of China, China National Biotec Group Co Ltd and the Wuhan Institute of Biological Products Co Ltd.)
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / China Follow-up duration (months): 2.33
	*
Inclusion criteria	Age range: healthy people aged 18-59 years old General good health as established by medical history and physical examination Since December 2019, the participant has not gone to Hubei province, overseas, or to a village/community where there had been COVID-19 cases, has not contacted with confirmed or suspected cases, are not in the quarantine period, and are not from a village/community where there were confirmed or suspected cases. Women of childbearing age are not pregnant (negative urine pregnancy test), are not breastfeeding, do not have pregnancy plan within the three months after enrollment, and have already taken effective contraceptive measures two weeks before enrollment Participants are able and willing to complete the whole research procedure in about 14 months Participants have the ability to understand the research procedures, to sign the informed consent voluntarily after explanation, and can comply with the requirements of the clinical research program
Exclusion criteria	Confirmed, suspected, or asymptomatic COVID-19 cases Those with positive antibody tests of the COVID-19 History of SARS virus infection (identified through self-report or on-site inquiry) Those with fever (axillary temperature >37.0 °C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath, and dyspnea within 14 days before inoculation Those with clinically abnormal parameters from blood biochemical, blood routine, and urine routine before inoculation (only for stage 1 clinical trial) Axillary temperature >37.0 °C before inoculation Those who have experienced severe allergic reactions (such as acute anaphylaxis, urticaria, eczema, dyspnea, neurovascular edema, or abdominal pain), or those who are allergic to the known gradients of COVID-19 inactivated vaccine Those with history or family history of convulsion, epilepsy, encephalopathy, or mental illness Those with congenital malformation, developmental disorder, genetic defect, or severe malnutrition, etc. Those with confirmed or suspected serious respiratory diseases, serious cardiovascular disease, severe liver or renal diseases, malignant tumors, uncontrolled hypertension (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg), diabetes complications, malignant tumors, or various acute or chronic diseases (acute attack stage) Those diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases Those with a history of abnormal coagulation (such as lack of coagulation factors or coagulation diseases) Those receiving anti-TB treatment Those receiving immune-enhancement or inhibitor treatment (p.o. or gtt.) over 14 days within 3 months (continuous oral or infusion for more than 14 days) Those receiving live-attenuated vaccines within one month before injection or other vaccines within 14 days before inoculation Those receiving blood products within 3 months before inoculation Those receiving other study drugs within 6 months before inoculation. Those under other conditions not suitable for the clinical trial (evaluated by researchers).After the first injection and before the subsequent second or third injection, the following participants were not allowed to be injected for the second or third injection or should be postponed for the injection: Women with positive urine pregnancy tests Those with high fever (axillary temperature ≥39.0 °C) lasting for three days or severe allergic reaction after the previous injection Serious adverse reactions related to the previous injection If the investigators found that the participant did not meet the inclusion criteria or the participant met the exclusion criteria after the first dose, investigators should decide whether the participants could continue to participate in the study Other reasons for exclusion evaluated by investigators.
Interventions
	Intervention 2 IM doses of 5-μg antigen protein content per dose,on days 0 and 14 2 IM doses of 5-μg antigen protein content per dose,on days 0 and 21
	Control 2 IM doses of 0.5-mg aluminum hydroxide content per dose,on days 0, 142 IM doses of 0.5-mg aluminum hydroxide content per dose,on days 0, 21
Participants
	Randomized * participants
	Characteristics of participants Type of participants: Healthy volunteers N=* 82 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Healthy adults, aged 18 to 59 years, without history ofSARS-CoV(via on-site inquiry) or SARS-CoV-2 infection (via serologicaland nucleic acid test
Primary outcome
	In the register Incidence of adverse reactions/events,
	In the report Injection site–specific adverse reactions and systemic adverse reactions within 7 days of each injection and the neutralizing antibody titers and the specific IgG-binding antibody titers
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: No Data accessibility: NR
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 report, the protocol, the statistical plan, the registry were used for the extraction and assessment of bias. This study achieved the ideal sample size. Incidence of seroconversion appears a secondary outcome in the registry and as primary in the report. Some secondary outcomes in the registry are not present in the report (e.g., Cellular immunity). Results for 180 days and 360 days after full vaccination in phase I not yet available.