Trial ChiCTR2000031809
Publication Guo W, EClinicalMedicine, 2021
Dates: 2020-04-12 to 2020-05-17
Funding: Public/non profit (National Program on Key Research Project of China; Major Science and Technology Project of the National New Drug Development of China)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / China Follow-up duration (months): 4.77 | |
| 2ยท5 mcg on days 0, 28, and 56 = 168 5 mcg on days 0, 28, and 56 = 168 10 mcg on days 0, 28, and 56 = 168 Placebo on days 0, 28, and 56 = 168 5 mcg on days 0 and 14 = 84 Placebo on days 0 and 14 = 28 5 mcg on days 0 and 21 = 84 Placebo on days 0 and 21 = 28 5 mcg on days 0 and 28 = 84 Placebo on days 0 and 28 = 28 10 mcg on day 0 = 84 Placebo on day 0 = 28 | |
| Inclusion criteria | Healthy, non-pregnant adults; aged 18 years or older; no known history of SARS-CoV-1 (via on-site inquiry) or SARS-CoV-2 infection (via serological and nucleic acid test); had not been to Hubei province, regions outside China, or other regions with confirmed COVID-19 cases; and had not contacted with confirmed or suspected cases. |
| Exclusion criteria | Respiratory diseases or symptoms within 14 days before vaccination; abnormalities in laboratory examinations; history of severe allergic reaction or allergy to ingredients in the vaccine; taking certain treatments or medications or other vaccines before the study as specified in Supplementary Appendix; and history of severe comorbidities that may affect the adherence. |
| Interventions | |
| Intervention
3 IM doses of 2.5 mcg, each 28 days apart 3 IM doses of 5 mcg, each 28 days apart 3 IM doses of 10 mcg, each 28 days apart 2 IM doses of 5 mcg, 14 days apart 2 IM doses of 5 mcg, 21 days apart 2 IM doses of 5 mcg, 28 days apart 1 IM dose of 10 mcg |
|
| Control
3 IM doses of adjuvant, each 28 days apart2 IM doses of adjuvant, 14 days apart2 IM doses of adjuvant, 21 days apart2 IM doses of adjuvant, 28 days apart1 IM dose of adjuvant | |
| Participants | |
| Randomized 1120 participants | |
| Characteristics of participants Type of participants: Healthy volunteers, Adults N=1120 522 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
| Description of participants Healthy adults with no history of COVID-19 at 5 centers in China. | |
| Primary outcome | |
| In the register Incidence of adverse reactions/events 0-7 days after each dose of vaccination | |
| In the report 7-day adverse reactions; neutralizing antibody titres and specific IgG binding antibody titres measured on days 28 and 90 after the whole-course vaccination | |
| Variants description | |
| Variants | |
| Description * | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, 6 months after the trial is 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 |
Some concerns |
| General comment | In addition to the published article, the trial protocol, statistical analysis plan, registry and supplementary materials were used in data extraction and assessment of risk of bias. There were outcomes in the registry not reported in the paper (Cellular immunity, Four-fold growth rate and antibody level (GMT, GMI) of COVID-19 antibody at 4 and 14 days before and after each dose of vaccination, 21 days after the first dose of vaccination). Otherwise there were no other substantive differences in population, procedures, interventions or outcomes between the published article and the trial protocol, statistical analysis plan and registry. The study achieved its target sample size. The article present pooled results for phase 1 and 2. For the purpose of this review we pooled the results for the same dose and schedule in different age groups. Other trial arms including children and adolescents are ongoing and are not included in this report. |