Trial ChiCTR2000032459
Publication Xia S, Lancet Infect Dis, 2020
Dates: 18/05/2020 to 30/07/2020
Funding: Mixed (National Program on Key Research Project of China, National Mega projects of China for Major Infectious Diseases, National Mega Projects of China for New Drug Creation, and Beijing Science and Technology Plan. The China National Biotec Group and the Beijing Institute of Biological Products provided the study product, and oversaw all trial operations.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Single center / China Follow-up duration (days): 28 | |
| * | |
| Inclusion criteria | Healthy subjects aged ≥18 years; no travel to Hubei province, outside the country or in a village/community where there has been an outbreak since December 2019; no exoosure to a person infected with or suspected of COVID-19; Female subjects with childbearing age not pregnant at the time of recruitment and are not nursing; Effective contraceptive measures taken within 2 weeks before inclusion; able to informed consent, and comply with the requirements of the clinical study protocol |
| Exclusion criteria | Confirmed, suspected or asymptomatic cases with COVID-19; Positive in serum antibodies (IgG and IgM) screening of COVID-19; history of SARS virus infection (self-reported, site information); Fever, dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath and dyspnea within 14 days before administration; abnormal indicators, such as blood biochemistry, blood routine and urine routine, which might show clinical meaning, before administration (only refers to Phase I); History of severe allergic reactions or allergy to known composition of COVID-19 vaccine; History of convulsion, epilepsy, encephalopathy or mental illness or family history; congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; severe liver and kidney diseases, uncontrollable hypertension, diabetic complications, malignant tumors, acute diseases or acute onset of chronic diseases; congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; history of coagulation dysfunction; Receiving anti-TB treatment; Receiving immunotherapy or inhibitor therapy within 3 months; vaccinated with live attenuated vaccine within 1 month, or other vaccine within 14 days before vaccination; Receiving blood products within 3 months before administration; Receiving other research drugs within 6 months before vaccination |
| Interventions | |
| Intervention
1 IM dose of 8-μg antigen protein content 2 IM doses of 4-μg antigen protein content per dose on days 0 and 14 2 IM doses of 4-μg antigen protein content per dose on days 0 and 21 2 IM doses of 4-μg antigen protein content per dose on days 0 and 28 |
|
| Control
1 IM dose of aluminum hydroxide2 IM doses of aluminum hydroxide on days 0 and 142 IM doses of aluminum hydroxide on days 0 and 212 IM doses of aluminum hydroxide on days 0 and 28 | |
| Participants | |
| Randomized * participants | |
| Characteristics of participants Type of participants: Healthy volunteers N=* 0 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: NR Age range: 18-59 years | |
| Description of participants Healthy SARS-CoV-2 serology negative adults 18-59 years old and ≥60 years old in a single centre in China | |
| Primary outcome | |
| In the register Incidence of adverse reactions/events 0-7 days after each dose of vaccination | |
| In the report adverse reactions within 7 days after the first and second vaccinations | |
| Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
Yes |
| 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 paper, the study registry was used in data extraction and risk of bias assessment. Protocol and statistical analysis plan were not available at time of extraction.The published article reports on both Phase 1 and Phase 2 trials of an inactivated SARS-CoV-2 vaccine. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. Regarding follow up days after last dose note that " For the 4 μg days 0 and 14 and days 0 and 21 schedules, neutralising antibody titres were measured 2 weeks (ie, on day 14) after the second inoculation in half of the participants, and 4 weeks (ie, on day 28) after the second inoculation in the other half of participants" |