Trial NCT04466085
Publication Yang S, Lancet, 2021
Dates: 12/07/2020 to 2020-07-17
Funding: Mixed (Nat’l Program on Key Research Project of China; Nat’l Science & Technology Major Projects of Drug Discovery, Strategic Priority Research Program of the Chinese Academy of Sciences; Anhui Zhifei Longcom Biopharmaceutical.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / China Follow-up duration (months): 12 | |
| •Placebo (aluminum hydroxide adjuvant) days 0, 30 (n=150) •ZF2001 25 mcg per 0.5 mL days 0, 30 (n=150) •ZF2001 50 mcg per 0.5 mL days 0, 30 (n=150) •aluminum hydroxide adjuvant, days 0, 30, 60 (n=150) • Placebo (aluminum hydroxide adjuvant) days 0, 30, 60 (n=150) •ZF2001 25 mcg per 0.5 mL days 0, 30, 60 (n=150) |
|
| Inclusion criteria | Eligible participants were healthy men and nonpregnant women, 18 to 59 years of age. Healthy status, assessed during the screening period, was based on medical history and clinical laboratory findings, vital signs, and physical examination. |
| Exclusion criteria | A history of SARS or COVID-19, or were tested positive for SARS-CoV-2 exposure (by real-time PCR assay or enzyme-linked immunosorbent assay [ELISA]), or contacted with confirmed COVID-19 patients; history of seizures or mental illness; allergy to any ingredient in the vaccine; acute febrile disease in 24 hours and digestive diseases in 7 days before enrollment; congenital or acquired immune diseases; serious chronic disease; abnormal chest CT image; positive test of HBV, HCV, HIV and syphilis; tumor patients; receipt of any blood products in the past 3 months; receipt of any research medicines or vaccine in the past 3 month; and being unable to comply with the study schedule |
| Interventions | |
| Intervention
2 IM doses of ZF2001 25 mcg 30 days apart 2 IM doses of ZF2001 50 mcg 30 days apart 3 IM doses of ZF2001 25 mcg 30 days apart 3 IM doses of ZF2001 50 mcg 30 days apart |
|
| Control
2 IM doses of Adjuvant 30 days apart3 IM doses of Adjuvant 30 days apart | |
| Participants | |
| Randomized 900 participants | |
| Characteristics of participants Type of participants: Healthy volunteers N=900 398 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 18.8-59.7 | |
| Description of participants Healthy SARS-CoV-2 infection-free adults aged 18-59 at 1 center in China | |
| Primary outcome | |
| In the register Neutralizing antibody positive conversion rate [ Time Frame: 30 days after inoculation ] | |
| In the report Safety and immunogenicity. | |
| Variants description | |
| Variants | |
| Description | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, The data will be made available immediately after publication and finalisation of the complete clinical study report, for at least 6 months. |
| 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, protocol, statistical and supplementary material were used in data extraction and assessment of risk of bias. The primary outcome in the registry was neutralizing antibody positive conversion rate whereas in the pre-print article the primary outcome included both safety and immunogenicity, but long term follow up is ongoing so this may be considered appropriate for this early report. Other than this there were no substantive differences between the registry and the pre-print article. Both studies achieved their pre-stated sample sizes. This trial was update on 16th April, 2021 after the publication of the study report. |